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Jul
11
ragupathyrenganathan
US FDA updates warnings for fluoroquinolone antibiotics on risks of mental health & low blood sugar adverse reactions
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Maryland
Wednesday, July 11, 2018, 18:00 Hrs  [IST]

The US Food and Drug Administration (FDA) is requiring safety labeling changes for a class of antibiotics called fluoroquinolones to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances, and make these warnings more consistent across the labeling for all fluoroquinolones taken by mouth or given by injection.

“The use of fluoroquinolones has a place in the treatment of serious bacterial infections — such as certain types of bacterial pneumonia — where the benefits of these drugs outweigh the risks, and they should remain available as a therapeutic option. The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that health care providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive) and delafloxacin (Baxdela). There are more than 60 generic versions. The safety labeling changes the FDA is requiring were based on a comprehensive review of the FDA’s adverse event reports and case reports published in medical literature.

Across the fluoroquinolone antibiotic class, a range of mental health side effects are already described in the Warnings and Precautions section of the drug labeling, but differed by individual drug. The new class-wide labeling changes will require that the mental health side effects be listed separately from other central nervous system side effects and be consistent across the labeling of the fluoroquinolone class. The mental health side effects to be included in the labeling across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium.

Additionally, the recent FDA review found instances of hypoglycemic coma where users of fluoroquinolones experienced hypoglycemia. As a result, the Blood Glucose Disturbances subsection of the labeling for all systemic fluoroquinolones will now be required to explicitly reflect the potential risk of coma with hypoglycemia.

Today, the FDA also published a drug safety communication about safety information regarding hypoglycemic coma and mental health side effects with fluoroquinolones.

The FDA first added a Boxed Warning to fluoroquinolones in July 2008 for the increased risk of tendinitis and tendon rupture. In February 2011, the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed Warning. In August 2013, the agency required updates to the labeling to describe the potential for irreversible peripheral neuropathy (serious nerve damage).

In 2016, the FDA enhanced warnings about the association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system. Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options.

The patient Medication Guide that is required to be given to the patient with each fluoroquinolone prescription describes the safety issues associated with these medicines.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

Courtesy – Pharmabiz

Mar
5
Sandeep Singh Dhillon
US Pharma Firms Concerned Over ‘HALAL’ Guidelines
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KUALA LUMPUR — US pharmaceutical companies have expressed concerns over the Health Ministry’s guideline on “halal” products, claiming preferential treatment.

The concern was among many issues highlighted by the Pharmaceutical Researchers and Manufacturers of America (PhRMA) in its annual submission to the US Trade Representative this month.

The report, which highlighted the challenges faced in key international markets for innovative pharmaceutical firms, was quoted by Fitch Group unit BMI Research in its follow-up publication released yesterday.

“According to (the ministry) 2017 guideline on halal pharmaceuticals, the government provides preferential treatment to medicines with halal ingredients in government procurement,” the report said.

“As such, PhRMA member companies are concerned that these guidelines could have unexpected negative implications on patients’ health.”

Last year, the Islamic Development Department of Malaysia (Jakim) became the first halal certifying body to certify controlled/prescriptive medicines (ethical products) based on the MS2424:2012 Halal Pharmaceuticals ― General Guidelines.

The current global halal pharmaceuticals prospect is valued at US$75 billion (RM331.9 billion), and estimated to reach US$132 billion by 2021.

PhRMA also complained that the ministry’s procurement process preferred locally-manufactured goods.

“The Malaysian government indirectly discourages an open and competitive marketplace for international pharmaceutical compounds through procurement preferences for locally manufactured products,” it said.

“For example, the government recently announced that it will grant three-year procurement contracts to companies that move production of imported products to Malaysia.”

This comes as PhRMA designated Malaysia a “priority foreign country”, together with South Korea in the region, complaining about what it saw as poor intellectual property (IP) protection and non-transparent compulsory licences (CLs).

“Malaysia’s designation as a ‘Priority Foreign Country’ in PhRMA’s 2018 submission highlights inadequate levels of intellectual property protection and mandatory medicine price disclosure as ongoing concerns for multinational drugmakers,” BMI said.

“Additionally, while the government has adopted a policy which prioritises the welfare of Malaysians, the use of a non-transparent process to issue compulsory licences as a method to coerce price reductions will continue to undermine investment by innovative drugmakers in the country.”

PhRMA highlighted so-called “onerous IP acts, policies and practices” and the use of CLs to promote the local production of medicines at the expense of manufacturers in the US.

“The non-transparent manner in which the announcement of the CL was made raised serious concerns as prior to the announcement, the Ministry of Health did not offer to meet with the relevant industry stakeholders to consider their concerns or evaluate their input,” BMI said.

The drugmakers stated that CLs issued by the Malaysian government “undermine a core tenant of IP protection and, if unaddressed, could inspire other countries to advance similar compulsory license schemes undermining vital IP”.

Feb
22
Sandeep Singh Dhillon
Biocon Malaysia unit gets FDA Form 483 notice – Times of India
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CHENNAI: Indian pharmaceutical giant Biocon on Wednesday told the BSE that the US-FDA (Food and Drugs Administration) has issued a Form 483 with six observations for its manufacturing facility in Malaysia.
Normally, the US-FDA issues the Form 483 when an inspection finds conditions in violations of food and drug safety. The company’s management is notified via Form 483 if the US-FDA team’s inspection has found “conditions or practices that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.”
Biocon told the BSE that it would come up with a corrective action plan.
“The US-FDA has completed a pre-approval inspection of our manufacturing facility in Malaysia and has issued a Form 483 with six observations. As per the normal expectations of the agency, we intend to respond with a corrective and preventive action plan in a timely manner,” said Rajeev Balakrishnan, company secretary, Biocon.
On its website, Biocon lists its insulin manufacturing facility at Johor, Malaysia, as its first overseas biopharma manufacturing and research unit, started in 2015 with an investment of $275 million.
Biocon Malaysia, which has launched biosimilars such as Basalog and Insugen, started commercial operations in 2017 and has GMP certification from the European Medical Agency.
Biocon already supplies insulin from this plant in Malaysia and expects the insulin supplies to Europe upon product approval.
The company has received USFDA approval for Glargine and the same is likely to have triggered the inspection. The company had also indicated of the same in the recently quarterly earning conference call.
Biocon’s biosimilar version of Roche’s Trastuzumab — a drug to treat breast and stomach cancer — received US FDA approval last December.

Feb
2
Sandeep Singh Dhillon
What Challenges Should Biosimilar Companies Expect In 2018? – Biosimilardevelopment.com
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By Anna Rose Welch, Editor, Biosimilar Development

What challenges do you expect biosimilar companies to run into in 2018, and what could be done to address these challenges?

A sustainable biosimilar medicines industry implies access to the global market, or at least a multi-region market. In the EU, the European Commission will undertake a debate on pharmaceutical incentives, which is a cornerstone to competition in the pharmaceutical and biologics market. One of the measures at stake, the supplementary patent protection manufacturing waiver, is of fundamental importance for biosimilar manufacturers established in the EU. The change would leave the EU IP landscape unaffected while, at the same time, enabling manufacturers to compete globally for markets where IP protection no longer exists, removing an unintentional adverse effect of the current legislation. This is particularly important in light of the key biologic product monopolies for which expiry is coming. The biggest of all challenges, in my opinion, will be for EU governments and policy makers to put their ambitions in motion, be it for competition in the biologics market or for EU industrial policy. Rather than grand plans and national policies, it may be important to start with small and tailored, yet concrete, policies so the benefits are tangible in a shorter time frame.

Julie Maréchal-Jamil, director biosimilars policy & science, Medicines for Europe

An ongoing challenge for companies will be considering commercialization challenges and solutions as well as policy and reimbursement trends and scenarios from the moment of product selection. Too many companies have focused entirely on selecting, developing, and investing in products alone, but this is not enough. Companies also have to build a strategy around a true path for differentiation and be clear as to what parts of the value chain will be owned by whom. Hence, you have to engage business development much earlier in the process. Waiting too long to do so greatly lowers options and returns while increasing risks and the possibility of early mistakes, even as far back as portfolio selection itself. In short, development and regulatory success are necessary but certainly not sufficient. One must engage more fully and proactively in policy and commercialization challenges and solutions — not just alone, but with partners and trade associations.

Edric Engert, managing director, Abraxeolus Consulting

Biosimilars will enable patients with active rheumatoid arthritis and inflammatory bowel disease to get the treatment in its early stages. For patients with lymphoma or breast/gastric cancer, biosimilars can improve access to therapeutically aggressive rituximab- or trastuzumab-based combination regimens. However, physicians and patients continue to emphasize concerns about switching from biologics to biosimilars. Therefore, biosimilar companies must have robust evidence to reassure the medical and patient community about the safety and efficacy of switching. For instance, studies like the NOR-SWITCH study or the pivotal randomized controlled trial of CT-P13 in Crohn’s disease have made a significant contribution to the evidence base for switching.

— HoUng Kim, head of strategy and operations, Celltrion

Market access remains a challenge for biosimilar companies, with patients, pharmacists, and physicians still unsure about biosimilars. Knowledge about and understanding of biosimilars and their development pathway are still lacking, and more education is required at a broader and deeper level. Stakeholders such as payers, regulatory agencies, and others in the healthcare sector should actively promote the use of biosimilars, explaining how they can promote sustainability of the healthcare system. In the EU, gainsharing has certainly helped the uptake of biosimilars, whereby the savings generated by patients taking biosimilars are shared between providers and payers. This acknowledges the efforts by providers in either initiating or switching patients to a biosimilar.

Sue Naeyaert, global head of pricing, market access, government affairs and policy, biosimilars, Fresenius Kabi SwissBioSim

One main challenge I expect biosimilar companies to run into in 2018 will be effectively balancing pricing that will enable profits and gain commercial payer reimbursement and management support. Biosimilar companies may face challenges to provide lower net-cost pricing relative to competing reference biologics in order to gain support from some commercial health plans. It is important to note this challenge does not apply to Medicare, because Medicare Advantage plans are restricted from providing utilization management support (though this actually could help increase market share for Part B biosimilars).

— Brian Lehman, strategic consultant, Humana Pharmacy Professional Affairs

One of the big challenges at the moment is finding enough patients to accommodate the requirements for clinical trials, seeing as more companies are bringing mainstream biosimilar drugs, such as anti-inflammatory drugs, into Phase 3 clinical trials. One way to address the challenge is by accessing patients in other geographic locations who haven’t been treated with these drugs, such as Eastern European countries, where the quality of medicine is high and standardized laboratory tests can be run at another site, such as in Western Europe. In the U.S., administrative burdens, such as documentation requirements and physician sign-off, can interfere with supporting patients in a clinical trial. This challenge could be addressed by streamlining the documentation required and presenting a harmonized approach to data collection and reporting, with support from regulatory agencies and industry associations.

Don Stewart, CEO, PlantForm

Patent litigation will continue to dampen the growth of the biosimilar market in the U.S. I’d argue public interest litigation and political pressure would help the situation. In general, a stronger biosimilar lobby would help significantly.

Pankaj Mohan, CEO, Oncobiologics

In my opinion, the greatest challenges biosimilar companies will face in 2018 are acceptance, patent challenges, and developing a successful marketing plan. A critical challenge facing biosimilar companies will be to educate the broader healthcare professional community and then patients about the basics of biosimilars. By necessity, education has until now focused on some professional societies and patient groups. While it is heartening to see an increase in their knowledge and acceptance, it will be more challenging to broaden this knowledge to the rank and file of healthcare professionals and to the ordinary patient so that biosimilars will be broadly accepted.

It has also become apparent that the thicket of patents surrounding reference products will delay the entry of many biosimilars. I am not an expert on patents, but still I recognize that negotiating a path forward in this area will be critical. Adoption of biosimilars in the U.S. once they are launched will also be a challenge. Zarxio has a very respectable market share two years after product launch, but it seems other biosimilars are facing challenges in adoption.

— Hillel Cohen, executive director, scientific affairs, Sandoz

*These statements represent the viewpoints of the individuals, not those of their employers.

This article originally appeared at https://www.biosimilardevelopment.com/doc/what-challenges-should-biosimilar-companies-expect-in-0001?vm_tId=2047638&user=c666d828-d506-40aa-bb3a-c74525efd4db&utm_source=et_6384992&utm_medium=email&utm_campaign=BIOS_02-01-2018&utm_term=c666d828-d506-40aa-bb3a-c74525efd4db&utm_content=What+Challenges+Should+Biosimilar+Companies+Expect+In+2018%253f

Jan
8
Sandeep Singh Dhillon
New Study Shows How Alcohol Damages DNA – Forbes
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Victoria Forster

Those abstaining from alcohol this month now have extra reason to be smug as a new study, published today in Nature sheds light on how alcohol damages DNA and increases the risk of cancer.

Scientists and doctors have previously linked alcohol to an increased risk of developing at least seven types of cancer, and attribute it to causing almost 20,000 cancer deaths in the USA per year, but until now, the exact way in which alcohol damages DNA has not been clear.

Scientists at the MRC Laboratory of Molecular Biology in the UK gave ethanol, the type of alcohol found in alcoholic beverages, to mice and then looked at their DNA to see what genetic damage had been sustained. They found that acetaldehyde, a breakdown product of ethanol, damaged the DNA within blood stem cells, leaving them riddled with mutations that could lead to cancer.

Professor Ketan Patel, the lead author of the study, said: “Some cancers develop due to DNA damage in stem cells. While some damage occurs by chance, our findings suggest that drinking alcohol can increase the risk of this damage.”

The study also investigated how the body breaks down alcohol and how this contributes to the risk of DNA damage after indulging. Aldehyde dehydrogenases (ALDH) are a group of enzymes which break down acetaldehyde into benign acetate, which can actually be used as a source of energy for cells and hence is a large part of the unfortunate calorie-burden of alcohol.

Worldwide, over half a billion people lack or have mutations in ALDH genes, meaning that after drinking, they get a build up of acetaldehyde, which also gives them a flushed complexion and can mean they feel unwell. People most likely to have these mutations are often of South East Asian heritage, including millions of Americans, but the deficiency can occur in people of any ethnicity.

The researchers gave ethanol to mice lacking ALDH2, the most important ALDH enzyme, and found that these mice had four times as much DNA damage in their cells when compared to mice who had the fully-functioning ALDH2 enzyme. This research adds to work that has previously suggested that people with ALDH2 deficiency were at greater risk of developing esophageal cancer after drinking.

The American Cancer Society recommends a maximum of one drink a day for women and two for men. However, this new study adds to a wave of recent expert opinion and evidence which suggests that there is no ‘safe limit’ for alcohol consumption and even minimal drinking will cause some level of DNA damage.

This article originally appeared at https://www.forbes.com/sites/victoriaforster/2018/01/03/not-doing-dryuary-you-might-want-to-reconsider-as-new-study-shows-how-alcohol-damages-dna/?ss=pharma-healthcare#7bbfa7ae50f6

Jan
3
Sandeep Singh Dhillon
New drug approvals hit 21-year high in 2017 – Reuters
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Ben Hirschler

LONDON (Reuters) – U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light — more than double the previous year — while the figure also rose in the European Union.

The EU recommended 92 new drugs including generics, up from 81, and China laid out plans to speed up approvals in what is now the world’s second biggest market behind the United States.

Yet the world’s biggest drugmakers saw average returns on their research and development spending fall, reflecting more competitive pressures and the growing share of new products now coming from younger biotech companies.

Consultancy Deloitte said last month that projected returns at 12 of the world’s top drugmakers were at an eight-year low of only 3.2 percent.

Many of the drugs receiving a green light in 2017 were for rare diseases and sub-types of cancer, which often target very small populations, although they can cost hundreds of thousands of dollars. (tmsnrt.rs/2hGom21)

Significantly, the U.S. drug tally of 46 does not include the first of a new wave of cell and gene therapies from Novartis, Gilead Sciences and Spark Therapeutics that were approved in 2017 under a separate category.

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has hailed these products as “a whole new scientific paradigm for the treatment of serious diseases”. However, there is debate as to how cash-strapped healthcare systems will pay for them.

Under Gottlieb, the FDA has taken advantage of policy changes implemented in recent years to accelerate the drug approval process.

Procedures such as the agency’s “breakthrough therapy” designation have cut review times and helped to stimulate competition by adding multiple new drugs that often work in a similar way.

A wide choice of medicines with the same mechanism of action can be a double-edged sword for manufacturers, since it gives insurers and governments ammunition to drive down prices.

Pfizer and Merck’s new diabetes drug Steglatro, for example, was the fourth product of its kind to win a green light in the United States, while Novo Nordisk’s Ozempic was the sixth of its type. Both were approved in December.

In cancer, AstraZeneca’s Imfinzi was the fifth medicine to target a key protein found on the body’s immune cells when it won approval last May.

For the current year, companies have more new products waiting in the wings, although the pace of FDA approvals may be tempered by the fact that several drugs that had been expected to be cleared in the first quarter of 2018 were actually approved in 2017.

In Europe, meanwhile, the focus will be on any disruption or delays to the approval process as the European Medicines Agency prepares to relocate from London to Amsterdam as a result of Britain’s decision to leave the European Union.

Reporting by Ben Hirschler; Editing by Keith Weir

This article originally appeared in https://www.reuters.com/article/us-pharmaceuticals-approvals/new-drug-approvals-hit-21-year-high-in-2017-idUSKBN1ER0P7

Dec
4
Sandeep Singh Dhillon
Brexit impact on UK pharma industry to be investigated – BBC News
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By Bill Wilson
Business reporter, BBC News

Brexit may affect the cost of medicines and hit UK pharmaceutical investment, a Commons committee head has warned.
Rachel Reeves, who chairs the Business, Energy and Industrial Strategy (BEIS) committee, says access to new medical products may also be at risk.
She said the uncertainty around Brexit was “very concerning”, as MPs prepare to examine its effects on the industry.
They include the sector’s access to highly skilled workers after the UK leaves the European Union.
Ms Reeves said the evidence MPs had received suggested Brexit could threaten “the cost of medicines, investment in the UK and access to new and innovative research and products”.
“There are serious concerns raised around the future regulation of pharmaceuticals, mutual recognition of medicines, and the prospect of damaging disruption to cross-EU drug supply chains,” she said.
“This is very concerning, with uncertainty risking the UK becoming a less desirable place for investment and development in a growing, productive industry.
“We are keen to examine the detail of these concerns and to hear from the industry what it wants from the government to ensure the smoothest possible transition as we leave the EU.”
Brexit will mean the relocation of the European Medicines Agency from London to Amsterdam.
The MPs’ inquiry comes despite the announcement last week of two big deals in the UK’s pharma sector.
The government said then that the decisions by MSD, known as Merck in North America, and Germany’s Qiagen illustrated confidence in its recently announced industrial strategy for when the UK leaves the EU.
The industrial strategy white paper outlines the government’s plans to support more research and development, encourage firms to embrace new technology and boost the economy.
A report in the Sunday Times said more major investment for the sector is due to be announced soon, with GlaxoSmithKline expected to reveal a new research partnership.
The Business committee has been seeking views from across the sector and has received written submissions from big pharmaceutical companies, trade unions, industry bodies and the government.
The submissions have been published ahead of a public evidence session on Tuesday when the committee will question witnesses from the industry on the impact of Brexit.
It will consider different outcomes relating to future cross-border customs and trading arrangements, and consider what the government should aim to achieve in negotiations.
Those appearing before the committee will include the Association of the British Pharmaceutical Industry (APBI) and Belgian-headquartered Janssen Pharmaceutical, part of US giant Johnson & Johnson.
The ABPI said the inquiry was important.
“The written evidence received by the committee highlights how regulatory cooperation, a frictionless system for trade and access to research funding, collaboration and talent, underpin the successful development and delivery of medicines,” a spokesperson said.
“Evidence also shows that 45 million packs of medicines go from Britain to the EU every month and 37 million come the other way. With this whole system at stake, clarity on medicines regulation and trade is urgently required for all patients across Europe.”

Full article at http://www.bbc.com/news/business-42213937

Nov
29
Sandeep Singh Dhillon
AstraZeneca and Chinese Future Industry Investment Fund establish joint venture to develop new medicines in China
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AstraZeneca today announced a strategic joint venture with the Chinese Future Industry Investment Fund (FIIF) to form an equally-owned, stand-alone company in China to discover, develop and commercialise potential new medicines to help meet unmet needs globally, and to bring innovative new medicines to patients in China faster. FIIF is managed by the SDIC Fund Management Company (SDIC Fund), a private equity management company.

The new company, Dizal Pharmaceutical, incorporates all scientific and technical capabilities of AstraZeneca’s Innovation Center China (ICC), and holds exclusive rights to develop and commercialise three potential medicines currently in pre-clinical development from AstraZeneca’s pipeline in its main therapy areas of oncology, cardiovascular and metabolic diseases, and respiratory. It is also expected to initiate novel clinical programmes. The FIIF will contribute funding and expertise in establishing strategic partnerships in China.

Dr. Xiaolin Zhang, previously Head of AstraZeneca’s ICC, has been named as Chief Executive Officer of the new company. All staff employed by the ICC have been invited to join the new company.

Pascal Soriot, Chief Executive Officer of AstraZeneca, said: “AstraZeneca has a long-standing and strong commitment to China, which we are reinforcing today with this ground-breaking joint venture. By joining forces with the FIIF, we aim to accelerate the local discovery and development of innovative, affordable medicines for patients in China and around the world.”

Guohua Gao, Chairman of SDIC Fund, said: “FIIF is delighted to be collaborating with AstraZeneca to promote the development of innovative medicines. AstraZeneca’s Innovation Center China has an excellent track record of drug discovery, and the synergy created by combining AstraZeneca’s scientific talent and assets with FIIF’s China expertise and funding will help further promote innovation in medical science.”

The remit of the FIIF in the pharmaceutical industry is to promote the development and manufacturing of innovative medicines in China through strategic partnerships. The joint venture supports AstraZeneca’s commitment to enhancing China’s research and development capabilities through diversified external partnerships that deliver value to patients in China.

SDIC Fund Management Company (SDIC Fund) is an independent private equity fund manager established in August 2009. It currently advises and manages more than RMB 60 billion of capital. The Future Industry Investment Fund is one of the funds that are managed by SDIC Fund. The limited partners of SDIC Fund include a wide range of institutional investors across China. The core strategy of SDIC Fund is to invest in market leading companies with attractive growth prospects and outstanding management teams. In partnership with the portfolio companies and their management teams, it aims to contribute strategically and add business value to the companies. SDIC Fund prides itself on its ability to forge effective and mutually rewarding partnerships with exceptional management teams to execute its strategy of investing in quality businesses, and adding value to make them grow to become leaders in their respective industry. SDIC Fund’s primary focus in China includes healthcare, advanced manufacturing, TMT and environmental protection.

About AstraZeneca in China

Since entering China in 1993, AstraZeneca has been committed to continuously following the science, focusing on innovation and becoming one of the most trusted healthcare partners to bring high quality, innovative medicines and complete disease solutions to Chinese patients from disease prevention to diagnosis, treatment and rehabilitation. We develop long-term partnerships with Government, academia and local scientists across research and development (R&D) and manufacturing.

AstraZeneca has end-to-end R&D capabilities in China, from discovery to clinical development and manufacturing of innovative medicines. Our comprehensive presence includes manufacturing sites in Wuxi and Taizhou and a China Distribution Centre in Wuxi. AstraZeneca’s China headquarters are based in Shanghai and the company has more than 11,000 employees throughout the country.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Full article is available at http://www.worldpharmanews.com/astrazeneca/4208-astrazeneca-and-chinese-future-industry-investment-fund-establish-joint-venture-to-develop-new-medicines-in-china

Nov
27
Sandeep Singh Dhillon
Roche Cancer Drug Rises To Challenge Merck, Bristol-Myers – Forbes
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By Matthew Herper

Tecentriq, a cancer immunotherapy developed by the Swiss drug giant Roche, slowed the progression of previously untreated lung cancer in a large clinical trial when combined with a chemotherapy regimen, the drug giant said.

“We are extremely encouraged by these results and will submit these data to health authorities globally with the goal of bringing a potential new standard of care for the initial treatment of lung cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer said in a press release

The news represents the latest upset among a class of new medicines that unlock the body’s ability to fight tumors. These medicines, called PD-1 inhibitors, are already big sellers for Bristol-Myers Squibb and Merck. In the third quarter of 2017, Bristol’s Opdivo generated $1.3 billion in sales; Merck’s Keytruda generated $1 billion. Financial analysts at Wall Street banks forecast that by 2022, these drugs will generate annual global sales of $25 billion a year, with the bulk of sales going to Bristol and Merck.

Merck has pulled ahead of Bristol, the pioneer in developing these drugs, because an early Merck trial in first-line lung cancer succeeded, while a similar study from Bristol failed, baffling investors and researchers. Keytruda is approved in advanced non-small lung cancer in patients whose tumors express a protein called PD-L1 above a certain level, or in combination with the chemotherapy drugs Alimta and carboplatin. Today’s Roche result complicates things further, because Roche used a different combination of drugs

Roche’s study had three arms. All patients received carboplatin and paclitaxel, the cancer drug once sold as Taxol. The control group also received Avastin, one of Roche’s best-selling cancer drugs. Then two groups got Tecentriq, one with Avastin and one without. What Roche has announced today is that the Avastin-Tecentriq-chemotherapy combination did better than Avastin and chemotherapy alone, and that the survival results so far are “encouraging.” That leaves a big question: how are the patients who got Tecentriq, but not Avastin, doing?

It’s impossible to know exactly what this will mean until the full results of the study are presented. (Companies release early results by press release because they are considered too important to investors to keep secret.) In morning trading, Roche shares are up as much as 5.6%, and Merck shares are down 2%. But two analysts, Umer Raffat of Evercore/ISI and Timothy Anderson at Bernstein Research. commented that the results could actually be seen as a validation of the general Merck approach of combining PD-1 drugs with chemotherapy. Rivals, including Bristol and AstraZeneca, have favored combining them with another type of immunotherapy drug, called a CTLA4 inhibitor, such as Bristol’s Yervoy.

One big question will be how the chemotherapy regimens stack up against the CTLA4 combinations. Another will be how they stack up against each other. How will doctors compare the Merck and Roche drug regimens? How will insurance companies decide which ones to cover? Anderson, the Bernstein analyst, said that investors are likely to not view Roche as a big threat because it is entering the market late. But he also wrote that the trial is “one important piece of a complex, still largely incomplete, puzzle.” Bernstein forecasts 2022 Tecentriq sales of $3.7 billion, less than half as much as for Opdivo or Keytruda.

Nov
24
Sandeep Singh Dhillon
Teva Pharmaceutical Set for Major Layoffs in Israel, U.S. – Reuters
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Teva Pharmaceutical is expected to cut up to a quarter of its 6,860-strong workforce in Israel, and a few thousand more staff in the United States, media reported Thursday, though a minister said the figures may not be accurate.

The world’s largest generic drugmaker will send termination letters to “tens of percent” of its 10,000 employees in the United States in coming weeks, Israeli financial news website Calcalist said, citing people familiar with the matter.

The debt-laden company’s stock closed up 4.6 percent in Tel Aviv on the report. A spokesman for Teva, which was seen as one of Israel’s great corporate success stories, declined to comment.

Teva had been widely expected to cut costs after warning this month it would miss 2017 profit forecasts due to falling prices of generics in the U.S. and weakening sales of its multiple sclerosis drug Copaxone.

Teva has also been saddled with nearly $35 billion in debt due to its $40.5-billion acquisition of Allergan’s generic drug business Actavis last year. Investors have been pushing for clarity on its future.

Teva has already been selling off assets to help meet its debt payments.

Teva’s new Chief Executive Kare Schultz was working out the details of the job cuts with regional management in Israel and the United States, Calcalist reported.

It said between 20-25 percent of the staff in Israel could go, including Michael Hayden, Teva’s chief scientific officer and president of research and development.

Israeli Economy Minister Eli Cohen told Reuters he had spoken with officials at Teva and was told that the numbers leaked to the media were off.

“I spoke to them this morning, they said the figures are not accurate,” Cohen said.

The Histadrut labour federation said it would not accept any unilateral moves by Teva’s management.

“Any efficiency measures, if and when they arise, will be done through negotiations and with the agreement of the Histadrut and the labour unions,” Histadrut spokesman Yaniv Levi said. “Lay-offs are the last resort.”

Fitch Ratings downgraded Teva’s debt to junk this month. (Editing by Andrew Heavens)

Read more: Teva Pharmaceutical Set for Major Layoffs in Israel, U.S. -Report | Investopedia https://www.investopedia.com/partner/reuters/teva-pharmaceutical-set-major-layoffs-israel-us-report/#ixzz4zMQtBcMy
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