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U.S. FDA warns Sun Pharma over standards at Halol plant

MUMBAI India’s largest drugmaker Sun Pharmaceutical Industries Ltd has been warned by U.S. health regulators for violating manufacturing standards at its Halol plant in India, even as it has been working on fixing issues at the plant for over a year. The U.S. ... More »

Novartis trial shows drug improves survival for AML patients

ZURICH Novartis’ phase III study for its acute myeloid leukemia (AML) drug showed it improved overall survival by 23 percent for patients with FLT3 mutations, the Swiss drugmaker said on Sunday. Basel-based Novartis said the study was the first large controlle... More »

Roche pulls out of ‘superbug’ antibiotic project

VIENNA Swiss drugmaker Roche Holding has dropped out of a high-profile project to develop an antibiotic for treating “superbug” infections, the company said on Sunday. Roche had agreed in 2013 to pay privately held partner Polyphor up to 500 million Swiss fran... More »

Guinea’s last Ebola case, a baby girl, leaves hospital

DAKAR A one-month-old baby girl who was Guinea’s last reported Ebola case left hospital on Saturday, delighting medical staff and putting the country on course to be declared free of the deadly virus. Guinea will become officially Ebola-free after 42 days if n... More »

Novartis gets FDA approval for skin cancer drug combination

Novartis AG said on Friday it received the U.S. Food and Drug Administration’s regular approval for a drug combination to treat an aggressive form of skin cancer. The FDA approved Tafinlar and Mekinist for treatment of metastatic melanoma based on two years ov... More »

FDA approves Baxalta’s drug for rare bleeding disorder

The U.S. Food and Drug Administration said on Friday it approved Baxalta Inc’s drug for use in patients with a type of rare bleeding disorder. The drug, Adynovate, was approved to control and reduce the frequency of bleeding episodes in patients with Hemophili... More »

Drug industry bemoans Britain’s lack of science skills

LONDON British pharmaceutical and biotechnology companies face a major skills shortage which threatens future investment and the long-term success of the life sciences sector, according to a new industry report. The Association of the British Pharmaceutical In... More »

Drugged up: GSK, Roche and Sanofi to set out their stalls

LONDON Three of Europe’s top drugmakers – GlaxoSmithKline, Roche and Sanofi – face health checks this week at high-profile presentations designed to show they can overcome looming market threats. The unusual confluence of investor days comes at a testing time ... More »

MERS, Ebola, bird flu: Science’s big missed opportunities

LONDON, Anyone who goes down with flu in Europe this winter could be asked to enroll in a randomized clinical trial in which they will either be given a drug, which may or may not work, or standard advice to take bed rest and paracetamol. Those who agree could... More »

WHO experts signal victory over one of three polio strains

GENEVA The world should stop vaccinating children against one of the three strains of the crippling polio virus as part of a drive to eradicate the disease once and for all, a group of health experts has advised the World Health Organization. There is no cure ... More »

Nestle spends $70 million on U.S. health science hub

ZURICH Nestle’s health science division is investing $70 million in a product technology center that will become the unit’s new U.S. headquarters and research hub, the division said on Friday. The Bridgewater, New Jersey center will further Nestle’s healthcare... More »

Women are missing from HIV drug trials

(Reuters Health) – Although women make up roughly half of the world’s HIV cases, they remain largely excluded from clinical trials testing drugs, vaccines and potential cures for the virus, a research review confirms. In an analysis spanning several decades th... More »

FDA expands approval of Merck’s Keytruda to lung cancer

The U.S. Food and Drug Administration on Friday approved Merck & Co Inc’s immunotherapy, Keytruda, for patients with the most common form of lung cancer whose tumors produce a specific biological marker. The FDA approval for Keytruda in advanced non-small cell... More »

Novo shares jump ahead of its largest ever drug launch

COPENHAGEN Shares in Novo Nordisk (NOVOb.CO) rose as much as 5 percent on Monday after the U.S. Food and Drug Administration (FDA) approved the diabetes drug Tresiba, allowing the Danish drugmaker to prepare its largest ever drug launch. The FDA’s decision lat... More »

Sanofi wins EU approval for Praluent anti-cholesterol drug

PARIS French drugmaker Sanofi said the European Commission had cleared its key cholesterol drug Praluent for the treatment of so-called “bad cholesterol,” or low-density lipoprotein (LDL) cholesterol, in certain adult patients with hypercholesterolemia. The dr... More »

Novartis to start human tests with Google lens in 2016

ZURICH Novartis plans the first human tests next year of a “smart” contact lens it is developing with Google designed to help restore the eye’s natural autofocus. “This project is progressing well,” Novartis Chief Executive Joe Jimenez told Swiss newspaper Le ... More »

Planned Parenthood fight hits Congress, wider impact unclear

WASHINGTON, August 3 Women’s health group Planned Parenthood, under attack by anti-abortionists posting hidden-camera videos online, will be the focus of a partisan showdown on Monday in the U.S. Senate, with any wider influence on voters from the charge still... More »

Gene therapy for deafness moves a few steps closer

LONDON Gene therapy for deafness is moving closer to reality, with new research on Wednesday showing the technique for fixing faulty DNA can improve responses in mice with genetic hearing loss. Separately, a clinical trial backed by Novartis is under way to he... More »