GSK Gets New CEO; Clinical Researchers to Become More Accountable

GSK gets new CEO; Clinical researchers to become more accountable

In global pharma news, GSK finally chose its head of consumer healthcare Emma Walmsley as the CEO to succeed Andrew Witty. Additionally, Phispers has news on acquisitions and a likely divestment, and on drugs like Sarepta’s medicine for Duchenne muscular dystrophy, Roche’s antimalarial drug Lariam and Novartis’ cancer drug Gleevec. Read on.

Insider Emma Walmsley to be the new CEO of GlaxoSmithKline

Emma Walmsley will succeed Andrew Witty as the chief executive officer of GlaxoSmithKline PLC, the British drug maker announced this week. Walmsley, 47, currently heads its consumer health care division. The board of GSK unanimously voted to elevate Walmsley, a GSK spokesperson said.

The move highlights the company’s growing emphasis on higher-volume, lower-margin drugstore staples such as toothpaste and painkillers, a Reuters report said.

Walmsley spent most of her career at cosmetics company L’Oréal SA before joining Glaxo six years ago. She will take up the post on March 31 next year, when Witty steps down. This will make GSK the first top-tier pharmaceutical company to be led by a woman. Witty has been the CEO since 2008. And in March this year, GSK had announced his planned departure.

Abbott to sell eye care business to J&J; Novartis doesn’t rule out Alcon sale

Abbott Laboratories announced that it will sell its eye care business to Johnson & Johnson for a cash consideration of US $ 4.33 billion in order to focus on cardiovascular devices and diagnostics business.

Abbott expanded its medical device and diagnostics businesses this year with two acquisitions -- St. Jude Medical Inc. for US $ 25 billion and Alere Inc. for US $ 5.8 billion.

However, the Alere deal has run into rough weather with Alere filing a lawsuit in August. Alere has accused Abbott of dragging its feet on key antitrust submissions.

Meanwhile, Novartis CEO Joe Jimenez has imposed a 2016-end deadline for the eye-care unit Alcon to get on to an upward sales trajectory. Novartis had acquired Alcon in December 2010.

At an M&A conference in Zurich last week, General Counsel of Novartis, Felix Ehrat, said he does not rule out the sale of Alcon. When asked if that means Novartis would not sell Alcon, he stepped away from that commitment. “Never say never," Ehrat said. Will Abbott get eye-care right after Novartis’ experience with Alcon?

Roche withdraws controversial anti-malarial drug Lariam in Ireland

This week, the Health Products Regulatory Authority confirmed that the marketing authorization for Lariam 250 mg tablets in Ireland was withdrawn by Roche Products Ltd in July this year.

Lariam is at the centre of a number of legal actions. There have been complaints about the drug and its alleged side effects from 50 serving or former members of the Defence Forces. Legal proceedings have been served in 37 cases. However, it will be several months before the first cases are ready to go for hearing in the High Court.

However, a spokesperson for Roche Products (Ireland) said the decision regarding Lariam was based on a portfolio reassessment and did not relate to pending legal cases. According to the spokesperson, Lariam remains available in 16 out of 23 European countries.

“The reason for the withdrawal, provided by Roche, was commercial,” Roche said in a statement.

Drug to treat Duchenne muscular dystrophy gets approved after unusual bickering

The FDA approved Sarepta Therapeutics’ drug for Duchenne muscular dystrophy after unusual bickering inside the FDA office. The drug will cost US $ 300,000 a year for the average patient in the United States. Analysts had expected a higher pricing.

Pricing of drugs has become a sensitive issue in the US, and has been a source of much public outcry. Several companies, in the past, would buy old medicines and hike their prices each year.

According to the Sarepta CEO, Dr Edward Kaye, the pricing was “in the middle of the range” for rare disease drugs. “Given the sensitivity to pricing, we tried to be reasonable when looking at all the costs,” he said.

Inside the FDA, there was debate over a key scientific question. The head of the drug review division was accused of being too intensely involved in the process for evaluating the medicine.

Allergan to acquire Tobira Therapeutics for US $ 1.7 billion

In its third acquisition this month, Allergan Plc said it would pay up to US $ 1.7 billion for Tobira Therapeutics in order to get a leg up in the race to develop therapies for NASH (non-alcoholic fatty liver disease) – an incurable fatty liver disease closely linked to obesity.

There are no approved treatments for NASH, which affects more than 15 million Americans. It involves the accumulation of fat in the liver not caused by alcohol, and can lead to cirrhosis, liver transplants or liver cancer.

UN report urges governments to ensure greater access to necessary drugs

This week, the United Nations released a report that urges governments to take steps to ensure greater access to necessary medicines. It contains several proposals that have previously caused friction with the pharmaceutical industry.

The UN report has been released amid concerns that too many people in a growing number of countries are not able to afford medicines – be it newer drugs or old remedies. The panel also addressed the concern that not enough is being done to develop drugs that treat diseases predominantly affecting the poor.

“Our hope is to boost R&D for neglected diseases — or better said for neglected patients — and to encourage governments to control prices and quality of the needed products,” Ruth Dreifuss, a former president of the Swiss Confederation and one of two co-chairs of the UN panel, said.

Colombia takes on Novartis, to reduce price of Gleevec

After weeks of deliberations, the Colombia health minister is going ahead with plans to unilaterally lower the price of a Novartis cancer drug – Gleevec – that has become the latest symbol of the battle between access to medicines and intellectual property rights.

Thought the amount of reduction in the price of the drug has not been announced, there were reports that Colombia’s Health Minister Alejandro Gaviria may drop the price for Gleevec by up to 45 percent.

According to patient advocacy groups, the annual cost of the drug is around US $ 15,000. While the country’s capita gross national income is only around US $ 8,000. This would amount to “significant savings for the whole health system,” the patient groups said.

Scientists to be held accountable for access to clinical trials in progress

The US Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have said that scientists conducting research need to be held accountable so that the public has timely access to clinical trials in progress, and their final results – be it positive or negative.

According to the HHS and NIH, problems arise when the study’s results are disappointing – a promising new drug formula turns out not to work in the way its developers hoped it would work, or if people experience unacceptable side effects. In such cases, the findings were often swept under the carpet.

Officials said the public had a right to know the negative results, too.

To make this happen, HHS is issuing a final rule with requirements on how and when researchers should register clinical trial information and submit results to ClinicalTrials.gov – a public online portal where anyone get information on the current clinical trials.

Under the new policy, most clinical trials receiving NIH funding will be required to participate and the studies will have to be registered in the ClinicalTrials.gov database within 21 days of enrolling their first participant, and final trial results must be posted no later than one year after a study is completed.

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