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Home » Newsletters » BioWorld

BioWorld

July 20, 2017

View Archived Issues

EU transparency watchdog probes EMA's interactions with biopharma industry

DUBLIN – The EU's transparency watchdog, the EU Ombudsman, has questioned whether the EMA has an overly cosy relationship with industry. Read More

Increases in NIH and FDA funding advance along congressional route

U.S. congressional appropriators continue to march to a different drumbeat than the cadence President Donald Trump directed for the NIH and FDA. Read More

Reimburse-Idis? Sarepta's MAP to Exondys 51 sales: Joint effort cuts DMD pain

As investors waited Wednesday afternoon for Sarepta Therapeutics Inc.'s second-quarter earnings, news of a managed access program (MAP) with Clinigen Group plc's Idis division for Exondys 51 (eteplirsen) in Duchenne muscular dystrophy (DMD) had Wall Street speculating that the deal would add to fiscal-year 2017 guidance of more than $95 million. Read More

Horama lines up gene therapy trial in recessive form of retinitis pigmentosa

DUBLIN – Horama SA, an early stage French gene therapy firm, is waiting for regulatory feedback on its first clinical trial authorization (CTA) before moving into clinical development. Read More

U.S. House ups ante on Medicare fraud efforts despite DoJ take-down

The House Ways and Means Committee met July 19 to examine the government's efforts to tamp down on Medicare fraud, but legislation is in the works that would increase the penalties for Medicare fraud even as the Department of Justice (DoJ) announced a series of arrests related to more than $1.3 billion in Medicare fraud. Read More

J&J devices outperform pharma in Q2, boosted by acquisitions, restructure

Medical device sales growth beat out that for pharmaceuticals in the latest quarter from Johnson & Johnson. That comes scarcely a year and a half after the conglomerate announced a restructuring of its devices business in the face of non-existent growth. Key to the boost has been acquisitions, which drove much of this quarter's gains. Read More

Memory deficits due to TBI can be reversed

Treating animals with a drug that inhibited the cellular integrated stress response could reverse memory deficits caused by traumatic brain injury (TBI), even if treatment was delayed for several weeks after the injury. Read More

Financings

Cymabay Therapeutics Inc., of Newark, Calif., said it priced its underwritten public offering of 13 million shares of its common stock at $6.50 each. Read More

Other news to note

Axovant Sciences GmbH, of Basel, Switzerland, reported data from a preclinical study in a poster presentation at the 2017 Alzheimer's Association International Conference in London. Read More

In the clinic

Tiziana Life Sciences plc, of London, said it enrolled the first patient in its phase IIa trial testing milciclib, a CDK inhibitor, in patients with refractory hepatocellular carcinoma (HCC). Read More

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