Aeglea BioTherapeutics Updates Phase I/II Trial Data
Aeglea BioTherapeutics announced new repeat dose data from its Phase I/II trial of AEB1102 (pegzilarginase) in patients with Arginase 1 Deficiency. Source: BioSpace
DOJ Official: Department’s Opioids Strategy Will Include Aggressive FCA Enforcement
As part of its multi-pronged campaign against the opioid epidemic, the Justice Department will continue its crackdown on opioid overprescribing through False Claims Act enforcement, according to a senior DOJ…
Impax Labs Settles Portion of Solodyn Pay-for-Delay Cases for $35 Million, as Trial Begins
Generic manufacturer Impax Laboratories agreed to pay $35 million to settle pay-for-delay lawsuits brought by a class of direct purchasers of the acne medication Solodyn (minocycline), sold by Medicis Pharmaceutical,…
FDA Generic Drug Approvals Remain Low in February
The FDA’s approvals of generic drugs picked up slightly in February after January’s steep dropoff, while overall ANDA submissions dropped sharply, according to the agency’s latest monthly report. Source: Drug…
1,200 Xarelto Liability Cases to be Selected for Trial Over the Next Six Months
A Louisiana federal judge managing the tide of lawsuits against the blood thinner Xarelto (rivaroxaban) ordered them to be prepared for trial in individual federal courts nationwide, with selection and…
Biogen Buys Pfizer's PhII-ready Schizophrenia Asset
Biogen is buying Pfizer’s PF-04958242, a first-in-class, Phase IIb-ready drug to treat several neurological and psychiatric diseases, including schizophrenia. Source: BioSpace
Sarepta to Seek FDA Approval for Second DMD Treatment
After a hard-fought battle to win the green light for Exondys 51 from the U.S. Food and Drug Administration, Sarepta Therapeutics is planning on seeking approval of a second treatment…
Hikma's Advair Generic Gets Further Delayed
Hikma Pharmaceuticals generic version of Advair has hit a stumbling block with the FDA. Source: BioSpace
Realm Therapeutics Flunks PhII Trial for Conjunctivitis Drug
Realm Therapeutics announced today that its PR013, failed to show efficacy in its Phase II trial for allergic conjunctivitis. Source: BioSpace
Anti-Obesity Drugmaker Orexigen Therapeutics Files for Bankruptcy
Shares of weight-loss drugmaker Orexigen Therapeutics are in free-fall this morning after the company announced it filed for bankruptcy. Source: BioSpace
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