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Home » Newsletters » BioWorld

BioWorld

July 20, 2021

View Archived Issues

Ardelyx shares crash as CKD drug hits trouble with FDA

Shares in Ardelyx Inc. have crashed after its tenapanor, under FDA review for managing phosphate levels in chronic kidney disease (CKD), ran into trouble with the regulator. The company said that the FDA has identified “deficiencies” in the data package, which prevent discussions about labeling and postmarketing commitments. Read More

Amylyx elixir, neuron-death fixer: $135M series C backs combo drug

Amylyx Pharmaceuticals Inc.’s oversubscribed, $135 million series C financing led by Viking Global Investors will help lay the groundwork for commercializing in Canada and Europe, as well as for a second phase III study in the U.S. with lead candidate AMX-0035 for amyotrophic lateral sclerosis. Read More
European investing illustration

Panakès Partners banks $177M at first close of second fund

DUBLIN – Panakès Partners SGR SpA has raised €150 million (US$177 million) in a first close of its second fund and is looking to secure a final tally of €180 million by year-end. That would represent more than twice the size of its first fund of €80 million and reflects its move into therapeutics investing. Read More

Rivus raises $35M to pursue mitochondrial uncoupling for cardiometabolic disease

Rivus Pharmaceuticals Inc. has emerged from stealth and disclosed a $35 million series A round to fund development of its pipeline of “controlled metabolic accelerators,” or CMAs, for treating cardiometabolic diseases. Read More
Lock on digital globe illustration

Cyber threats: Enough is enough, nations tell China

Responding to the growing number of state-sponsored cyber threats to health care and other key sectors and to the compromise of the Microsoft Exchange Server, which was disclosed in March, Canada, the EU, U.K., U.S. and other NATO allies issued statements July 19 laying out expectations and markers for how responsible nations behave in cyberspace and specifically calling out China’s “malicious cyber activity.” Read More

First therapy for rare liver disease PFIC, as Albireo’s Bylvay earns priority FDA nod

Albireo Pharma Inc.’s Bylvay (odevixibat) becomes the first therapy to hit the commercial market for rare genetic liver disease progressive familial intrahepatic cholestasis (PFIC). A day after the European Commission approved the drug, the FDA gave the nod to the ileal bile acid transport inhibitor on its July 20 PDUFA date following a priority review. Read More
Hands holding gears

Junshi and Immorna launch JV to develop mRNA therapeutics and vaccines

Junshi Biosciences Co. Ltd. entered an agreement with Immorna Biotechnology Co. Ltd. to establish a joint venture (JV) as part of its efforts to expand into the mRNA sector. Read More

Preclinical data: Immunome’s cocktail holds Delta variant at bay

New preclinical data from Immunome Inc. gets the company closer to the clinic for studying its three-antibody cocktail’s effect on SARS-CoV-2. “We will file an IND this quarter and get into the clinic,” Immunome’s CEO, Purnanand Sarma, told BioWorld. “Since the number of cases is rising, unfortunately, we think a clinical study could be conducted reasonably quickly.” Read More
Eye and DNA

Eluminex brings in late-stage biosynthetic cornea from Fibrogen in $108M deal

In a deal worth up to $108 million, ophthalmic startup Eluminex Biosciences Ltd. has licensed the global rights to Fibrogen Inc.’s biosynthetic cornea derived from recombinant human collagen (RHC) type III intended to tackle corneal blindness. Read More
Rendering of the Cell Shuttle

Cellares launches new Cell Shuttle partnership

Cellares Corp. added Poseida Therapeutics Inc. to its expanding early access partnership program (EAPP) for the company's Cell Shuttle, a highly specialized "factory in a box" solution for development of cell therapies. San Diego-based Poseida brings two autologous CAR-T product candidates to the program and joins Pact Pharma Inc. and Fred Hutchinson Cancer Research Center in the EAPP. Read More

U.S. drug distributors settle opioid suit for $1.2B

Three of the largest biopharma distributors in the U.S. agreed to a settlement of $1.179 billion with New York, bowing out of the state’s ongoing opioid lawsuit. Read More

Appointments and advancements for July 20, 2021

New hires and promotions in the biopharma industry, including: Arbor, Arcus, Assembly, Enochian, Eqrx, Mindset, Recro, TCR2, Tracon. Read More

Financings for July 20, 2021

Biopharmas raising money in public or private financings, including: Aesther, Bioplus, Brickell, Cytokinetics, HCW, Immunic, IMV, Jatt, Orbit, Remedybio, Sunshine. Read More

In the clinic for July 20, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aronora, Bone, Celsion, Compugen, Cytodyn, Cytokinetics, Frontier, Gilead, Nanoscope, Navidea, Nrx, Prometheus, Receptor Life Sciences, Redhill, Roche, Samsung, Valneva, Vertex, Viiv. Read More

Other news to note for July 20, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affinia, Ambiopharm, Creative Medical, CV Sciences, Creative Biolabs, Enzolytics, Everest Medicines, Eyepoint, Genfleet, Imeka, Inmune Bio, Insilico Medicine, Isa, Meditrust Health, Recce, Selva, Xeris. Read More

Regulatory actions for July 20, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Almirall, Aquestive, Astrazeneca, Bluerock, Elucida, G1, Kadmon, Kyowa Kirin, Lyndra, Merck & Co., Oblato, Receptor Life Sciences, Sinovac, Xenikos, Yisheng. Read More

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