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Biogen Licenses Mitsubishi Tanabe Pharma’s Phase 2 Molecule for Autoimmune Diseases

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Biogen (NASDAQ:BIIB) today announced an agreement to exclusively license MT-1303, a late stage experimental medicine with potential in multiple autoimmune indications, from Mitsubishi Tanabe Pharma Corporation (MTPC) (TSE: 4508). MT-1303 is an oral compound that targets the sphingosine 1-phosphate (S1P) receptor. read more

Mylan to Launch Offer for Perrigo Directly to Perrigo Shareholders on Sept. 14

HERTFORDSHIRE, England and PITTSBURGH, Sept. 8, 2015 /PRNewswire/ — Mylan N.V. (NASDAQ: MYL) today announced its intention to commence on Sept. 14, 2015 its formal offer to exchange all outstanding ordinary shares of Perrigo Company plc (NYSE: PRGO; TASE). Under the terms of the offer, Perrigo shareholders will receive $75 in cash and 2.3 Mylan ordinary shares for each Perrigo ordinary share .read more

Valeant And Progenics Announce FDA Acceptance Of NDA Submission For Oral RELISTOR®

LAVAL, Quebec and TARRYTOWN, N.Y., Sept. 8, 2015 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Valeant’s New Drug Application for RELISTOR® (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of April 16, 2016. read more

EarlySense Partners with Beurer for European Rollout of Contact-Free Sleep and Wellness Sensor  

RAMAT GAN, Israel, September 9, 2015 /PRNewswire/ —

EarlySense®, the market leader in contact-free, health and wellness sensing and analytics, announced today a major commercial agreement with Beurer, a leading European player in the health and well-being field.  Named the “SE 80 SleepExpert,” the new product will provide real-time sleep-pattern information to the user. The partnership leverages EarlySense’s core contact-free monitoring technology and products, originally designed for hospitals, and utilizes Beurer’s extensive distribution expertise and channels.

Essentialis Announces the Dosing of the First Prader-Willi Syndrome Patients in a Long-Term Extension to Clinical Trial PC025

CARLSBAD, Calif., Sept. 9, 2015 /PRNewswire/ — Essentialis announced today the dosing of the first Prader-Willi syndrome (PWS) patients in the long-term extension to clinical study PC025.  Patients who completed the first two phases of clinical study PC025 are currently being enrolled in a 6-month open label extension.  The objective of the extension is to document the long-term therapeutic benefits of DCCR, Essentialis’ lead drug, on hyperphagia, body fat, lean body mass, aggressive, threatening and destructive behaviors and on stamina.  The 6-month extension is being run by Dr. Virginia Kimonis’ team and the staff of the ICTS at the University of California, Irvine. read more

Egalet Announces Commercial Launch of OXAYDO™, the First and Only Immediate-Release Oxycodone Designed to Discourage Intranasal Abuse, and Launch of IMPACT-Rx, a Patient Access Initiative  

WAYNE, Pa., Sept. 9, 2015 /PRNewswire/ — Egalet Corporation (Nasdaq: EGLT) (“Egalet”), a fully integrated specialty pharmaceutical company focused on discovering, developing and commercializing innovative pain treatments, today announced the launch of OXAYDO™ (oxycodone HCI, USP) tablets -CII in the United States. OXAYDO is an immediate-release (IR) oral formulation of oxycodone HCl indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate. OXAYDO is the first and only IR oxycodone that is designed to discourage abuse via the route of snorting. OXAYDO can be taken without regard to food, the way opioids generally are taken. read more

FDA Grants Genentech’s Alectinib Priority Review for Specific Type of ALK-Positive Lung Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for alectinib, an oral investigational anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of people with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Alectinib was granted Breakthrough Therapy Designation by the FDA in June 2013 for people with ALK-positive NSCLC whose disease progressed on crizotinib.  read more

AstraZeneca Presents Further Evidence for the Potential of AZD9291 in First-Line and Pre-Treated Non-Small Cell Lung Cancer

LONDON–(EON: Enhanced Online News)–AstraZeneca today announced updated data on AZD9291 in first-line patients with epidermal growth factor receptor mutation (EGFRm) positive advanced non-small cell lung cancer (NSCLC) and previously-treated patients with EGFRm T790M mutation-positive NSCLC. The data being presented today at the World Conference on Lung Cancer (WCLC) 2015 were from the AURA Phase I trial first-line cohort and two AURA Phase II studies. read more

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