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FDA panel backs Valeant psoriasis drug with risk program

Valeant Pharmaceuticals International Inc.’s experimental drug to treat the skin disorder psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide.

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U.S. antitrust officials set to block Anthem, Aetna deals: Bloomberg

U.S. antitrust officials are expected to file lawsuits to block Anthem Inc.’s acquisition of Cigna Corp. as well as Aetna Inc.’s takeover of Humana Inc., Bloomberg reported, citing a person familiar with the matter.

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FDA knocks back biosimilar version of Neulasta

U.S. regulators have declined to approve Novartis’ so-called biosimilar copy of Amgen’s Neulasta drug that fights infections in cancer patients.

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J&J shares on track for record high

J&J raised its full-year 2016 sales and earnings forecasts and reported quarterly results that beat estimates, helped by strength in its Rx drugs business.

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Ionis Pharmaceuticals Licenses First Oral Antisense Drug Acting Locally in the GI Tract to Janssen

Ionis Pharmaceuticals Inc. announced that it has earned $10 million from Janssen Biotech Inc. upon licensing IONIS-JBI1-2.5Rx, an orally delivered antisense drug designed to locally inhibit an undisclosed target in the gastrointestinal tract for the treatment of a GI autoimmune disease. Janssen will assume all global development, regulatory and commercialization responsibilities for IONIS-JBI1-2.5Rx once Ionis completes the IND-enabling studies.

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Celgene and Jounce Reach $2.5 Billion Deal

Jounce Therapeutics, a private biotech company headquartered in Cambridge, Massachusetts, inked a licensing and development deal with Celgene Corporation that could hit $2.5 billion.

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Novartis warns 2016 profit may fall on higher heart drug spending

Novartis warned its profit may decline during 2016 as it ramps up marketing spending on new heart failure drug Entresto following a disappointing start for the medicine.

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Old pharma sees new profit cure in cancer drugs

Some of the world’s largest drug companies are taking out their checkbooks for acquisitions of smaller peers whose cancer drugs have the potential to cure not just patients, but corporate growth prospects as well.

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Study shows durable benefits of early HIV treatment

Early treatment of the human immunodeficiency virus (HIV) can dramatically reduce the odds of passing the deadly disease on to others, and the protection persists for years, according to final results from a major study that looked at the timing of antiretroviral therapy (ART).

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Brainstorm’s cell therapy succeeds in ALS mid-stage study

Brainstorm Cell Therapeutics Inc. said its experimental cell therapy was safe and well tolerated in patients with amyotrophic lateral sclerosis (ALS), a progressive neurological disorder, in a mid-stage study.

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Lymphoma Drug Flunks Phase III Test

Gazyva combined with chemotherapy failed to meet its primary endpoints in a Phase III trial for patients with previously untreated diffuse large B-cell lymphoma.

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AstraZeneca PLC Announces MedImmune Layoffs, But Does Not Specify Numbers or Location

According to Derek Lowe, writing in his “In The Pipeline” blog for Science Translational Medicine on July 15, AstraZeneca has announced job cuts at its MedImmune division. The gist of the rumors was confirmed by a Friday, July 15 statement released by the company.

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China approves GSK’s Cervarix for cervical cancer

The China Food and Drug Administration has approved GSK’s human papillomavirus vaccine Cervarix for use in the country to help women fight cervical cancer.

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AstraZeneca’s lung cancer drug meets main goal in late-stage trial

AstraZeneca Plc said its experimental lung cancer drug Tagrisso met its main goal in a late-stage study.

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Samsung Bioepis seeks Europe approval for its Humira copy

Biosimilars maker Samsung Bioepis, part of South Korea’s top family-run conglomerate Samsung Group, said it is seeking regulatory approval in Europe to sell its copy of AbbVie Inc.’s rheumatoid arthritis drug Humira.

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Herbalife settles pyramid scheme case with regulator, in blow to Pershing’s Ackman

Herbalife Ltd. agreed to a $200 million settlement with U.S. regulators under which the dietary supplements maker will change the way it does business and avoid being labeled a pyramid scheme, a blow to hedge fund manager Bill Ackman who for years has been betting against the company.

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Valeant psoriasis drug’s suicide risk hard to assess

Valeant’s experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, according to an FDA preliminary review.

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Pharma Bro Martin Shkreli Gets Trial Date, Couldn’t Wait to Play Pokémon Go After Hearing

Martin Shkreli will finally have his day in court. The disgraced former pharmaceutical entrepreneur will face a judge in June 2017, Reuters reported.

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Juno Stock Falls Again After Correcting Number of Trial Deaths

Juno Therapeutics has indicated that instead of three patient fatalities out of 129 cases for the company’s Phase II clinical trial of JCAR015 for relapsed or refractory B cell acute lymphoblastic leukemia, there were actually four.

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Ziopharm Reports Clinical Trial Death

Boston’s Ziopharm Oncology released information that a patient receiving gene therapy into a brain tumor died from an intracranial hemorrhage.

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