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Home » Newsletters » BioWorld

BioWorld

Dec. 13, 2019

View Archived Issues
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The eyes have it: Adcom slam-dunk vote favors Horizon thyroid candidate

As expected, Horizon Pharma plc sailed through the meeting of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee regarding the BLA for teprotumumab in thyroid eye disease (TED) with few surprises but much discussion. Read More

Transgene shows TG-4010 the guillotine after NSCLC trial miss

Transgene SA is quitting development of one of its lead therapeutic vaccines after a combination of the candidate, TG-4010, with chemotherapy and Opdivo missed its primary endpoint in a phase II trial evaluating the combination as a first-line treatment for certain advanced non-squamous non-small-cell lung cancers. Read More

Two positive CHMP opinions in December take 2019 tally to 41

DUBLIN – The European Medicines Agency’s Committee for Medicinal Products for Human Use closed out its year’s work with positive opinions on two applications, Novartis AG’s Beovu (brolucizumab) in wet age-related macular degeneration and Merck & Co. Inc.’s Recarbrio for treating gram negative infections in adults. Read More

Sarepta’s Vyondys 53 wins a surprise accelerated approval

In August the FDA was skeptical about Sarepta Therapeutics Inc.’s injectable Vyondys 53 (golodirsen), but that changed swiftly Friday with the agency’s accelerated approval for the Duchenne muscular dystrophy (DMD) follow-on therapy, the first treatment specifically for this subtype. Read More

EMA takes pharmacovigilance to the next level: ‘Nearly’ real-time decision-making

LONDON – Over the next decade pharmacovigilance will move on from a sole focus on adverse drug reactions (ADRs) to encompass monitoring of the in-market efficacy of medicines, according to Guido Rasi, executive director of EMA. Read More

Cautious optimism for Biolinerx’s CXCR4 inhibitor in pancreatic cancer

HONG KONG – Israel-based Biolinerx Ltd. has unveiled the latest data from its ongoing phase IIa COMBAT/KEYNOTE-202 study at the European Society of Medical Oncology Immuno-Oncology Congress 2019 which evaluates Biolinerx’s BL-8040, an inhibitor of the chemokine receptor CXCR4. Read More

Dec. 9-13, 2019 week in review: Biopharmas impress investors at ASH

A quick look back at top stories. Read More

Appointments and advancements for Dec. 13, 2019

New hires and promotions in the biopharma industry. Read More
EGFR-Bench-Press-12-13-hero

Bench Press for Dec. 13, 2019

BioWorld looks at translational medicine. Read More

Financings for Dec. 13, 2019

Biopharmas raising money in public or private financings. Read More

In the clinic for Dec. 13, 2019

Clinical updates, including trial initiations, enrollment status and data readouts and publications. Read More

Other news to note for Dec. 13, 2019

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief.

Read More

Regulatory actions for Dec. 13, 2019

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More

Regulatory front for Dec. 13, 2019

The latest global regulatory news, changes and updates affecting biopharma. Read More

Money raised by biopharma: 2019 vs. 2018

Total raised in public, private and other financings of biopharma companies, comparing 2019 vs. 2018. Read More

Biopharma money raised: Jan. 1-Dec. 12, 2019

Year-to-date money raised in public, private and other financings of biopharma companies. Read More

Phase I clinical trials: November 2019

Therapeutic area data reported by biopharma companies on phase I trials in November 2019. Read More

Phase II clinical trials: November 2019

Therapeutic area data reported by biopharma companies on phase II trials in December 2019. Read More

Phase III clinical trials: November 2019

Therapeutic area data reported by biopharma companies on phase III trials in November 2019. Read More

Biggest gainers and losers for the week of Dec. 9-13, 2019

The top 10 biopharma stock gainers and losers for the week. Read More

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