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BioWorld - Sunday, December 14, 2025
Home » Newsletters » BioWorld

BioWorld

Sep. 26, 2018

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Thinking outside the box: Copiktra proviso chagrins investors but not analysts

Wall Street apparently wasn't much pleased with the boxed warning on Verastem Inc.'s first approved product, trimming shares (NASDAQ:VSTM) by 19.6 percent, or $1.74, so they closed Tuesday at $7.15, even though analysts pointed out that the side effects with Copiktra (duvelisib) can be handled by doctors. Read More

TG nixes accelerated approval plan for CLL combo therapy

Shares of TG Therapeutics Inc. plunged 44.3 percent to $5.15 on Tuesday as uncertainty over timing of a key interim readout for its two-drug chronic lymphocytic leukemia (CLL) treatment led it to scrub plans to seek accelerated approval for the combo. Read More

More for Morphic: $80M series B to send two oral integrins to clinic

Existing investor Omega Funds linked up with new backer Novo Holdings to co-lead the $80 million series B for Morphic Therapeutic Inc. New investors Invus and Ecor1 Capital and Morphic's other series A investors joined the round, designed to propel the company's lead small-molecule integrin modulator and a follow-on oral integrin candidate through IND-enabling and clinical proof-of-concept studies. Read More

Promiscuity, long-term planning are solutions for diagnostics, their developers

PHILADELPHIA – Accurate diagnosis is a prerequisite for precision medicine. But diagnostics as a whole languishes in the provinces. Read More

Pharmacy gag clauses move closer to extinction

It looks like pharmacy gag clauses are going the way of dinosaurs. Following the lead of the Senate, the House Tuesday passed by voice vote two bills banning the insurance gag clauses that have kept pharmacists from letting patients know that paying out of pocket might be cheaper than their copay for a prescription drug. Read More

Herantis Pharma: Finnish science in translation

DUBLIN – By late 2019, early stage Finnish biotech firm Herantis Pharma plc aims to have a readout from its lead development program, which involves the intracerebral delivery of a first-in-class neurotrophic growth factor to Parkinson's disease patients, and to have completed recruitment onto a phase I/II trial of a novel gene therapy in patients with lymphedema arising from breast cancer treatment. Read More

Other news to note

Novosteo Inc., a West Lafayette, Ind.-based startup developing fracture-targeted bone anabolic agents intended to selectively accumulate on the bone fracture surface to accelerate healing, has won a $1.7 million SBIR phase I/II grant from the NIH. The grant is expected to help the Purdue University-affiliated company with testing and preparation for phase I trials. Read More

Financings

Orphan Star Therapeutics LLC, of New York, said it secured a commitment of $20 million from an undisclosed pharmaceutical partner. The funds will allow the company to advance its early stage pipeline of product candidates for several rare diseases, including Canavan disease, a rare genetic neurodegenerative disease that is usually fatal within the first decade of life. Read More

Regulatory front

The U.S. House of Representatives Tuesday passed, by voice vote, a bill that would reauthorize for the second time the Pandemic and All-Hazards Preparedness Act (PAHPA), which funds the nation's emergency stockpile of medical products, the development of medical countermeasures and responses to infectious diseases and pandemic flu.  Read More

Clinical data for Sept. 25, 2018

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Regulatory actions for Sept. 25, 2018

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