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BioWorld - Monday, December 15, 2025
Home » Newsletters » BioWorld

BioWorld

Oct. 19, 2015

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Negative market conditions blamed; Acacia follows Shield, postpones IPO

LONDON – Acacia Pharma Group plc became the second UK company in two weeks to postpone an IPO on the London Stock Exchange citing current uncertain market conditions. Read More

Boehringer wins FDA approval for Pradaxa antidote, Praxbind

A fast-acting antidote for Boehringer Ingelheim GmbH’s blockbuster Pradaxa (dabigatran) won accelerated FDA approval Friday, becoming the first approved agent for reversing the widely used anticoagulant. Read More

Infusion confusion? Cempra phase III results pain Wall Street despite CABP endpoint win

Cempra Inc.’s stock (NASDAQ:CEMP) lost 28 percent of its value Friday to close at $19.29, down $7.49, as investors balked at infusion-site pain reactions reported in the otherwise successful, second phase III trial with solithromycin for community-acquired bacterial pneumonia (CABP). Read More

Astrazeneca hit with CRL for DPP-4/SGLT2 diabetes combo drug

DUBLIN – Astrazeneca plc’s competitive efforts in type 2 diabetes, one of its key growth platforms, hit a setback when the FDA issued a complete response letter for its saxa/dapa combination of DPP-4 inhibitor saxagliptin and SGLT2 inhibitor dapagliflozin. Read More

Melanoma metastases helped by antioxidants

Antioxidants were once the darlings of cancer prevention – and in some consumer health publications, they still are. Eat blueberries, drink coffee, live forever. Read More

Wanted in LatAm: Biotech clusters to foster cooperation

RIO DE JANEIRO – Latin America still doesn’t have biotech clusters, an important tool to boost economic growth and drive research, said industry experts at the BIO Latin American conference recently, adding that, to succeed, the region will have to create the environment and the ecosystem to develop such clusters. Read More

FDA puts partial hold on Zafgen trials; screening for PWS patients

A partial clinical hold placed by the FDA on two Zafgen Inc. trials following a participant’s death continued to hold company shares (NASDAQ:ZFGN) near an all-time low Friday, pushing them $10.66 lower, or 50.7 percent, to close at $10.36. Read More

FDA’s Califf addresses overhaul of combo products regime

Only the U.S. Senate can say for certain whether Robert Califf will be the next commissioner of the FDA, but the cardiologist is demonstrating some leadership on an agency function that has been a sore spot for many in industry: regulation of combination products, which combine drugs, devices and/or biologic materials. Read More

Stock movers

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Financings

Hutchison China Meditech Ltd. (Chi-Med), of Hong Kong, filed an F-1 statement with the SEC seeking to list up to $100 million of its American depositary shares (ADS) on Nasdaq and trade under the ticker HCM. Read More

Other news to note

Arqule Inc., of Burlington, Mass., disclosed the publication of a paper detailing the preclinical profile of ARQ 092 and ARQ 751, orally available selective pan-AKT inhibitors. Read More

In the clinic

strong>Agios Pharmaceuticals Inc., of Cambridge, Mass., announced plans for multiple early stage combination studies of AG-220 and AG-221 in front-line acute myeloid leukemia (AML) during a special R&D day event. Read More

Bench Press: BioWorld looks at translational medicine

Two studies have shown that Ebola virus can persist in semen for at least nine months after an infection, and there is at least one case where Ebola virus in semen infected a survivor's sexual partner. Read More

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