APPROVALS

Soleno Therapeutics secures U.S. FDA approval for VYKAT XR to treat hyperphagia in Prader-Willi syndrome

The U.S. Food and Drug Administration (FDA) has approved Soleno Therapeutics' VYKAT XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the treatment of hyperphagia in adults...

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Launches

Initiative launched to assess sustainability of digital vs. traditional clinical trial approaches

The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, is launching the next phase of its project to...

PSL advances vacuum tray drying technology with modular solutions for the pharmaceutical, biopharmaceutical and fine chemical industries

PSL (Powder Systems Limited), a global leader in solid-liquid separation and drying solutions, has enhanced its CakeStand™ vacuum tray dryer, featuring modular options tailored...

Roche launches new innovation center in Boston

The Roche Genentech Innovation Center Boston has launched at Harvard’s Enterprise Research Campus in Allston, strengthening a long-standing partnership in areas such as disease...

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Supply Chain

NeoGenomics expands oncology testing reach with acquisition of Pathline

NeoGenomics, a provider of oncology testing services, has acquired Pathline, a CLIA/CAP/NYS-certified laboratory based in New Jersey. The acquisition strengthens NeoGenomics’ commercial presence in the...

Pharmanovia signs exclusive distribution agreement with Er-Kim for Sunosi in Eastern Europe

Pharmanovia has signed an exclusive distribution agreement with Er-Kim, to enhance the availability of Sunosi (Solriamfetol), a first-in-class treatment for Excessive Daytime Sleepiness (EDS),...

Dr. Reddy’s enters into collaboration with Henlius for commercialization of HLX15, a biosimilar candidate to Darzalex & Darzalex Faspro in the U.S. and Europe

Dr. Reddy’s Laboratories has entered into a license agreement with Shanghai Henlius Biotech for the commercialization of HLX15, Henlius’ investigational daratumumab biosimilar candidate to...

Er-Kim signs distribution agreement with the MEDICE Health Family for Vafseo in Central & Eastern Europe

Er-Kim, an international company specializing in the commercialization of novel therapies for pharmaceutical and biopharmaceutical companies, has signed a distribution agreement with the MEDICE...

Approvals

Soleno Therapeutics secures U.S. FDA approval for VYKAT XR to treat hyperphagia in Prader-Willi syndrome

The U.S. Food and Drug Administration (FDA) has approved Soleno Therapeutics' VYKAT XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the...

Qfitlia approved as first therapy in US to treat hemophilia A or B with or without inhibitors

The US Food and Drug Administration (FDA) has approved Sanofi's Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce...

Blujepa approved by US FDA for treatment of uncomplicated urinary tract infections

Dupixent approved as first biologic medicine in Japan for patients with COPD

TIVDAK approved in Japan for advanced or recurrent cervical cancer that has progressed on or after chemotherapy

SKYCLARYS approved by Health Canada for Friedreich’s ataxia

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R&D

AstraZeneca to invest $2.5bn in global strategic R&D centre, biotech agreements and manufacturing in Beijing

AstraZeneca is to invest $2.5 billion in Beijing to establish its sixth global strategic R&D centre together with major research and manufacturing agreements that...
R&D

Return on investment in pharma R&D rises with GLP-1 drugs helping drive growth

The return on investment in pharma research and development (R&D) has increased from the previous year, with GLP-1 drugs helping to boost growth, according...
R&D

Chlamydia vaccine candidate granted US FDA fast track designation

The US Food and Drug Administration has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention of chlamydia infection. The decision...
R&D

AstraZeneca enters license agreement with Alteogen for subcutaneous formulations of oncology assets

AstraZeneca and Alteogen have entered into an exclusive license agreement for ALT-B4, a novel hyaluronidase utilising Hybrozyme platform technology. Under the terms of the agreement,...
R&D

Atsena Therapeutics granted U.S. FDA Fast Track designation for gene therapy to treat X-linked retinoschisis

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Atsena Therapeutics' ATSN-201 for the treatment of X-linked retinoschisis (XLRS). ATSN-201, a...

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