Biopharmaceutical News Week 29/30
Celgene acquires Receptos for $7.2 billion and gets access to ozanimod, a novel, potential best-in-class, oral, once-daily, selective sphingosine 1-phosphate 1 and 5 receptor modulator (S1P) as a treatment for ulcerative colitis and relapsing multiple sclerosis.
Valeant Pharmaceuticals acquires Amoun Pharmaceutical (Egypt) in a deal worth $800 million and gives the company a presence in Africa and the Middle East.
Mylan’s independent Dutch foundation- known in Dutch as a stichting- has exercised an option to acquire shares that let it control 50% of the company and plans to block Teva’s hostile bid
Edwards acquires CardiAQ for $350 million and enters the transcatheter mitral valve replacement market.
St. Jude Medical announced its intention to acquire Thoratec, the maker of ventricular assist devices for $3.4 billion.
Anthem acquires Cigna in $54.2 billion deal, the largest-ever health insurance transaction.
Immunocore, a UK based biotech company raises $320 million, the largest private finance placement ever in Europe
Approval of drugs, vaccines, diagnostics and devices
The European Committee for Medicinal Products for Human Use (CHMP) recommends the approval of GSK’s Mosquirix, the first malaria vaccine to be approved anywhere in the world.
The European Commission approves Amgen’s Repatha (evolocumab) for the treatment of primary hypercholesterolemia. The drug, a monoclonal antibody, is the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor ever approved.
With more approval in Europe and the US:
The European Commission approves:
– Merck’ Keytruda (pembrolizumab) as a treatment for advance melanoma
– Bristol-Myers Squibb’s Opdivo (nivolumab) as a treatment for advanced metastatic non-small cell lung cancer.
– Janssen’s Imbruvica (ibrutinib), a selective Bruton kinase inhibitor, which becomes the first therapy to be specifically approved for the rare blood cancer Waldenström's macroglobulinemia.
The US FDA approves:
– Ipsen Biopharmaceuticals’s (France) Dysport or abobotulinumtoxin A for use in patients with upper limb spasticity.
– Lundbeck’s and Otsuka Pharmaceutical’s Rexulti (brexpiprazole) as a treatment of schizophrenia and as an adjunctive therapy to treat major depression.
– Novartis’ Odomzo (sonidegib) as a treatment of basal cell skin carcinoma.
– AstraZeneca’s Iressa as a first-line treatment for non-small cell lung cancer (NSCL) in patients with certain types of epidermal growth factor receptor mutations. The approval was given because AZ could use a new companion test developed by Qiagen to identify EGFR mutations in tumors, which will be used to tag new NSCLC patients eligible for Iressa.
– …..and at the same time Qiagen‘s companion diagnostic test for AstraZeneca’s Iressa lung cancer drug
Drugs at clinical stage
AstraZeneca’s selumetinib fails in a late stage uveal melanoma, a rare eye cancer trial.
Medical Devices and Diagnosis News
Gentag, Mayo Clinic, NovioSense and the Fraunhofer Institute for Microelectronic Circuits and System form a new Joint Venture to develop a next generation system to monitor diabetes.
Olivier Brandicourt, Sanofi’s new CEO announces a reorganization of its Operation into five business units; General Medicines & Emerging Markets, Specialty Care Global Business Unit to be named Sanofi Genzyme, Diabetes & Cardiovascular Business Unit, Sanofi Pasteur and Merial.
University of California Los Angeles (UCLA) Health indicates that cyber criminal attack hit part of its network that contains the medical records of an estimated 4.5 million people.
- Pharmaceutical Congress Asia 2025 on August 3-6 in Singapore
- 3rd Annual Nordic Life Science Days Partnering Conference on September 9-10 in Stockholm (Sweden)
- BioPharm America 2015 on September 15-17 in Boston (USA)
- Innovation Days on October 5-6 in Paris (France)
- BIO Japan on October 13-16 in Yokohama (Japan)
- BIO Latin America on October 14-16 in Rio de Janeiro (Brazil).
- 15th Annual Biotech in Europe Forum for Global Partnering & Investment on September 29-30 in Basel (Switzerland)
- BIO Europe 2015 on November 2-4 in Munich (Germany)
- Biofit 2015 on December 1-2 in Strasbourg (France)
Author: Jean-Claude Muller, Special Advisor at I&IR, firstname.lastname@example.org
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