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Pharma companies increasingly to focus on stability studies as norms from US FDA, WHO and D&C Rules mandate product safety information
Pharma Extra, Pharma News

Indian pharma companies now need to increasingly focus on stability studies to prove the safety of formulation till the end of the shelf life. The industry already has three regulations to adhere: Drugs & Cosmetic Rules, US FDA and WHO stability testing guidelines for API, finished drugs and the ICH norms on the same.

The purpose of the stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. It also calls for storage conditions, retest periods and shelf life of the products, said B Kumar, deputy drugs controller, sub-zonal office, CDSCO, Bengaluru.

In order to ensure that the drug formulations marketed in the country are stable till the end of the shelf life, it is necessary that stability studies should be brought under the condition of license for manufacturing drugs especially in Rule 71, 71-B & Rule 76, he added.

Delving on the submission of data for a stability study at the recently concluded seminar organized jointly by the Karnataka drugs control department and the KDPMA, Kumar said these are based on the written and approved stability protocol and not merely based on standard operating procedures. These are generally carried out at quality control laboratories.

With regards to the revised guidance of the D&C Rules, regulatory requirements of stability studies issued on April 10, 2018, mandates the applicants to submit evidence of stability, safety of excipients among others to the State Licensing Authority before grant of product manufacturing license for any product. Schedule M requires the manufacturers to conduct the stability study to ensure stability of the manufactured products too, he said.

The factors affecting stability studies are the storage time, storage conditions, type of storage forms, container and closure system. Here, Kumar went on to state that the longer the storage time, the more potential for degradation of the drug and more deterioration of dosage forms. Even the container closure system may affect the stability of drug. For instance, the plastic containers and rubber closures are reported to absorb antioxidants and preservatives from the solutions in contact leading to destabilization and microbial attack. Some of the stability problems also span from visible to particulate contamination, formation of gas and change in colour, he noted.

The three types of stability testing are accelerated stability studies, intermediate testing studies and long-term stability studies. Further, testing should be done using the containers and closures proposed for storage and distribution. Here the test should also include containers and closures for physician sample, besides promotion and marketing sample and bulk storage sample. The protocol should provide information about type, size and storage of containers and closures. Extensive studies must be done before selection of container-closure system, said Kumar.

Courtesy – Pharmabiz

Mylan introduces generic Brevibloc in US markets
Drug Discovery, Formulation Discussion, Pharma News
Hertfordshire, England
Saturday, September 15, 2018, 12:00 Hrs  [IST]

Global pharmaceutical company Mylan N.V. announced the US launch of esmolol hydrochloride in sodium chloride injection, 2,500 mg/250 mL (10 mg/mL) single-dose plastic bag and 2,000 mg/100 mL (20 mg/mL) single-dose plastic bag, the first generic version of the reference listed drug, Baxter’s Brevibloc.

Mylan is offering esmolol hydrochloride in sodium chloride injection, 2,500 mg/250 mL (10 mg/mL) single-dose plastic bag and 2,000 mg/100 mL (20 mg/mL) single-dose plastic bag to its institutional customers after an Abbreviated New Drug Application (ANDA) for the product was approved by the US Food and Drug Administration (FDA). Esmolol hydrochloride in sodium chloride injection is indicated for the short-term treatment of control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia and control of perioperative tachycardia and hypertension.

US sales for sodium chloride injection, 2,500 mg/250 mL (10 mg/mL) single-dose plastic bag and 2,000 mg/100 mL (20 mg/mL) single-dose plastic bag were approximately US$ 126 million for the 12 months ending June 30, 2018, according to IQVIA.

Currently, Mylan has 189 ANDAs pending FDA approval representing approximately US$ 91.5 billion in annual brand sales, according to IQVIA. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing US$ 50.6 billion in annual brand sales, for the 12 months ending June 30, 2018, according to IQVIA.

Courtesy – Pharnabiz

Researcher admits plot to steal GSK secrets to sell in China!!!!!
Intellectual Property Rights, Pharma News


Sep – 01-2018

Prosecutors have described the 48-year-old US citizen as one of the top protein biochemists in the world. She had worked at GlaxoSmithKline’s research facility in suburban Philadelphia for about a decade and had become a senior manager.

A cancer researcher pleaded guilty on Friday to conspiring to steal biopharmaceutical trade secrets from GlaxoSmithKline in what prosecutors said was a scheme that involved plans to set up companies in China to market them.Yu Xue entered a guilty plea in federal court on Friday to a single conspiracy count. The government dropped more than two dozen other pending counts against the researcher as part of the plea.

In court on Friday, Xue said she didn’t understand that the material she was emailing to her private account then to others including portions of her own patent application for certain research was considered trade secrets. “A trade secret to me is not publicly available. The patents I sent to them is publicly available,” she said, noting that she sent the preliminary application for a patent on her research.

Judge Joel Slomsky noted that prosecutors did not have to prove that she understood it was a trade secret, but that she knew she was sharing confidential materials. Slomsky said he believed federal prosecutors had met that burden of proof.

Prosecutors have described the 48-year-old US citizen as one of the top protein biochemists in the world. She had worked at GlaxoSmithKline’s research facility in suburban Philadelphia for about a decade and had become a senior manager. She was fired shortly after charges were brought against her in early 2016.

Prosecutors had accused her of downloading and emailing confidential information including research on specific cancer drugs and working with four others, including two people in China, charged in connection with the scheme.

Another research scientist at GlaxoSmithKline, Tao Li, was also charged as part of the five. She has a change of plea hearing scheduled before the court in a few weeks, but it was unclear if she would be pleading to the same charge as Xue.

Slomsky set a sentencing hearing for December 18, but agreed to hold an evidentiary hearing prior to that date that will largely focus on the difference between prosecutors’ and defense attorneys’ arguments about how serious the crime was and how much potential financial damage was caused.

“There are vast differences between the parties as to the value and importance of the information stolen,” Assistant US Attorney Robert Livermore said.

Federal prosecutors have had to drop charges or withdraw cases in several other high-profile trade secret cases in recent years, including that of Temple University professor Xiaoxing Xi, who was accused of stealing sensitive technology involving superconductivity in 2015.

Charges were dropped when investigators realized the information shared did not amount to trade secrets.

Courtesy – Business Today

US FDA updates warnings for fluoroquinolone antibiotics on risks of mental health & low blood sugar adverse reactions
Pharma News

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

Sandeep Singh Dhillon
US Pharma Firms Concerned Over ‘HALAL’ Guidelines
Pharma News
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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”.

Sandeep Singh Dhillon
Biocon Malaysia unit gets FDA Form 483 notice – Times of India
Pharma Extra, Pharma News
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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.

Sandeep Singh Dhillon
What Challenges Should Biosimilar Companies Expect In 2018? – Biosimilardevelopment.com
Pharma News
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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

Sandeep Singh Dhillon
New Study Shows How Alcohol Damages DNA – Forbes
Pharma News

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

Sandeep Singh Dhillon
New drug approvals hit 21-year high in 2017 – Reuters
Pharma News, Pharma Notables
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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

Sandeep Singh Dhillon
Brexit impact on UK pharma industry to be investigated – BBC News
Pharma News, Pharma Notables
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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