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The Pulse of the Pharmaceutical Industry

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One in five U.S. adolescents has sustained a concussion

Nearly 20 percent of American adolescents, or one in five, has suffered a concussion, according to newly released statistics.

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Newly discovered protein could help diagnose chronic brain disease: study

Researchers have discovered a protein that could help diagnose a degenerative brain disease commonly found in athletes, veterans of military service and others who have experienced brain trauma.

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U.S. picks companies to help make rules for advanced personal health monitors

Digital devices designed to monitor the wearer’s health in much greater detail than current models will need regulatory approval, and Apple Inc., Fitbit Inc. and seven other companies will take part in a program to speed the approval process, the U.S. health regulator said.

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FDA pours cold water on PTC Therapeutics’ Duchenne drug application

PTC Therapeutics Inc. failed to supply persuasive evidence that its experimental drug to treat a form of Duchenne muscular dystrophy is effective, the U.S. Food and Drug Administration said, dealing a blow to the company’s years-long effort to bring the drug to market.

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EU drugs watchdog warns of staff exodus if move from London botched

Europe’s drugs regulator could lose more than 70 percent of staff, making it unable to function, if politicians pick the wrong new home for the London-based agency, it warned on Tuesday.

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Axovant to pull plug on Alzheimer’s drug

Drug developer Axovant Sciences Ltd. said it would stop testing the company’s lead drug in Alzheimer’s after it failed to meet the main goals of a late-stage trial.

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Incoming Novartis CEO Lays Out ‘Productivity Revolution’ Quest in First Interview

New Novartis Chief Executive Officer Vasant Narasimhan has a goal of saving 25 percent of clinical trial costs by using digital technology.

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Genocea Shifts R&D Focus in Restructuring

Genocea Biosciences is pivoting a development strategy to focus on development of neoantigen cancer treatments and scrapping its Phase III-ready herpes drug.

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Obamacare repeal on the ropes as pivotal Republican rebuffs Trump

  By Susan Cornwell, Yasmeen Abutaleb   WASHINGTON (Reuters) – U.S. Senator Susan Collins rebuffed intense lobbying from fellow Republicans and the promise of money for her state in deciding on Monday to oppose – and likely doom – her party’s last-ditch effort to repeal Obamacare. The most moderate of Republican senators joined John McCain […]

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U.S. FDA joins Interpol crackdown on illicit online pharmacies

Authorities from a record 123 countries, including the U.S. FDA, have taken action against hundreds of businesses suspected of illegally selling medicines over the internet, officials said.

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FDA declines to approve opioid painkiller

The FDA declined to approve Intellipharmaceutics International ‘s long-acting opioid painkiller in its current form.

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FDA Rejects J&J’s RA Drug Sirukumab

The U.S. FDA issued a Complete Response Letter calling for additional clinical data to evaluate the safety of Janssen’s rheumatoid arthritis drug sirukumab.

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Pfizer Spins Off Four of Its Best Drug Candidates Into a Startup With $103 Million

Pfizer launched a six-person biotech startup, SpringWorks Therapeutics, with a $103 million Series A financing. Joining Pfizer in funding the company was Bain Capital Life Sciences, Bain Capital Double Impact, OrbiMed and LifeArc, formerly known as MRC Technology.

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PureTech’s Gelesis says obesity drug achieved weight loss in study

PureTech subsidiary Gelesis is moving closer to filing for regulatory approval of its obesity treatment Gelesis100 after results of the latest study, the company said.

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Republicans revise Obamacare repeal bill amid tepid support

U.S. senators made a last-ditch effort to secure support for the latest Republican attempt to repeal former President Barack Obama’s signature healthcare law, releasing revised legislation to appeal to undecided senators.

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Roche cancer immunotherapy Tecentriq wins EU approval

Roche immunotherapy Tecentriq won European Union approval for treating advanced lung and bladder cancer, the Swiss drugmaker said.

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Native American tribe moves to dismiss Allergan patent case

A Native American tribe holding patents for drugmaker Allergan Plc moved to dismiss a case brought by generic drug company Mylan NV challenging the patents.

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Versartis Growth Hormone Drug Fails Phase III Test

Versartis Inc. said the company’s experimental human growth hormone somavaratan failed to meet endpoints in a critical Phase III trial.

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Japan health minister to consider U.S. drug firms’ views in pricing overhaul

Japan will weigh the concerns of U.S. drug firms in its efforts to complete by year-end a drastic revision of its drug-pricing system, aimed at reining in medical spending and cutting the public burden, the health minister said.

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Recent Cyberattack on Merck & Co. Could Lead to Drug Shortage

Federal lawmakers are concerned that a recent cyberattack on pharma giant Merck & Co. could lead to numerous problems. including a drug shortage.

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