Pharma readings

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Sanofi epilepsy drug linked to over 4,000 child deformities

French regulator says women taking the valproate were four times more likely to give birth to babies with malformities<p>The epilepsy medication valproate is responsible for “severe malformations” in up to 4,100 children in France since the drug was first marketed in the country in 1967, according to …


Roche claims another FDA green light for Tecentriq

<b>Roche's Genentech unit has been granted a speedy FDA approval for PD-L1 inhibitor Tecentriq as a first-line treatment for bladder cancer, extending</b> …


Novartis Predicts Chinese Drug Market Growth Will Accelerate - Bloomberg

Swiss drugmaker Novartis AG expects growth in China’s pharmaceuticals market to accelerate as the nation’s health authorities expedite approvals for …


UK hasn’t given up on keeping European Medicines Agency

<b>The UK’s chief Brexit negotiator, minister David Davis will fight to keep the European Medicines Agency in London, despite the country leaving the EU.</b><p>…


Eli Lilly shares are cratering after the FDA rejected a $1 billion arthritis drug on safety concerns

Shares of Eli Lilly dropped more than 5 percent in the premarket Monday after the Food and Drug Administration rejected its drug to treat rheumatoid …


Roche's Tecentriq wins FDA approval for treating advanced bladder cancer

(Reuters) - Genentech, a unit of Swiss drugmaker Roche Holding AG, said on Monday it got approval from the U.S. Food and Drug Administration for its already approved immunotherapy drug, Tecentriq, to treat advanced bladder cancer.<p>Tecentriq, also known as atezolizumab, received the go-ahead under …

Genetic Testing
European Union

FDA approval for 23andMe’s direct-to-consumer genetics test

<b>In a landmark decision from the FDA, genomics firm 23andMe’s direct-to-consumer genetics test has been approved in 10 conditions.</b>Originally given FDA …

Genetic Testing

AstraZeneca under pressure amid caution over cancer drug trial

AstraZeneca came under pressure on Wednesday after UBS turned cautious ahead of results from a pivotal lung cancer drug trial.<p>The clinical study, …


Roche's Alecensa Succeeds in Lung Cancer Study (RHHBY)

Roche AG’s (RHHBY) announced that its oral ALK inhibitor therapy, Alecensa (alectinib), met its primary endpoint in a Phase 3 study. The study …


Questor: the onslaught of generic drugs is a bitter pill the new boss of Glaxo must swallow

<b>Glaxo: £16.60</b><p><b>Questor says HOLD</b><p>A little piece of good news greeted the beginning of Emma Walmsley’s reign at GlaxoSmithKline last week.<p>An application by rival Mylan to market a generic copy of the British group’s blockbuster drug Advair was rejected by the US Food and Drug Administration.<p>It will be …


Five big challenges Emma Walmsley faces at the helm of GSK

When Emma Walmsley takes the reins at GlaxoSmithKline, the British drugmaker, on Monday she will become the first female chief executive of a major …

U.S. approves Roche drug that targets severe form of MS

ZURICH (Reuters) - Roche's multiple sclerosis (MS) drug Ocrevus won U.S. approval, putting the potential blockbuster back on track after a brief delay and giving a lift to patients with a form of the disease that until now had no approved treatment.<p>The drug, also known as ocrelizumab and …

Health Care

Trump Is Slashing FDA Rules. Why Isn’t Big Pharma Excited?

President Donald Trump is planning to take the ax to Food and Drug Administration regulations. “[We’re] going to be streamlining the process so that, …

Johnson & Johnson

Chinese drug approval boosts AstraZeneca's lung cancer hopes

LONDON (Reuters) - AstraZeneca has won approval for its lung cancer pill Tagrisso in China, a key market for the potential blockbuster medicine.<p>Tagrisso is designed to help cancer patients with certain genetic mutations that are very common in China and the regulatory green light boosts the British …

21st Century

Merck KgaA, Pfizer Cancer Drug to Cost $13,000 a Month

Pfizer and Merck KGaA’s cancer immunotherapy won approval from U.S. regulators for patients with a rare form of skin cancer, and the companies plan …