Top Pharma News of the Week

All The Most Important Pharmaceutical News Stories Of The Week – February 2018 – Week #4

AbbVie and Voyager Therapeutics Announce Global Strategic Collaboration to Develop Potential New Treatments for Alzheimer’s Disease and Other Tau-Related Neurodegenerative Diseases

February 20, 2018

AbbVie and Voyager Therapeutics, Inc., a clinical-stage gene therapy company, today announced that they have entered into an exclusive strategic collaboration and option agreement to develop and commercialize vectorized antibodies directed against tau for the treatment of Alzheimer’s disease and other neurodegenerative diseases. This collaboration combines AbbVie’s monoclonal antibody expertise, global clinical development and commercial capabilities with Voyager’s gene therapy platform and expertise that enables generating adeno-associated viral (AAV) vectors for the treatment of neurodegenerative diseases.

Merck and Viralytics Announce Acquisition Agreement, Expanding Merck’s Leading Immuno-Oncology Pipeline

February 21, 2018

Merck, known as MSD outside the United States and Canada, and Viralytics Limited have announced that the companies have signed a definitive agreement under which it is proposed that Merck, through a subsidiary, will acquire Viralytics, an Australian publicly traded company focused on oncolytic immunotherapy treatments for a range of cancers by way of a scheme of arrangement (Scheme) for AUD 1.75 cash per Viralytics share. The proposed acquisition values the total issued shares in Viralytics at approximately AUD 502 million (USD 394 million). The cash consideration of AUD 1.75 per share represents a premium of 160% to the one month volume weighted average price (VWAP) of Viralytics shares.

AbbVie Announces Positive Topline Results from Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids

February 21, 2018

AbbVie in cooperation with Neurocrine Biosciences, Inc., announced that the Phase 3 ELARIS UF-I study (M12-815) of elagolix met its primary endpoint. Results from the first of two pivotal Phase 3 studies demonstrated at month six that elagolix, in combination with low-dose hormone (add-back) therapy, reduced heavy menstrual bleeding with 68.5 percent (p<0.001) of women with uterine fibroids achieving clinical response compared to placebo (8.7 percent), as measured by the alkaline hematin method. Clinical response was defined as menstrual blood loss volume of less than 80 mL during month six and a 50 percent or greater reduction in menstrual blood loss volume from baseline to month six. The study also met all ranked secondary endpoints (p<0.001) at month six.

Ferring Pharmaceuticals and Merck Announce Completion of Largest Clinical Trial Ever Conducted in Postpartum Hemorrhage

February 22, 2018

Ferring Pharmaceuticals and Merck, known as MSD outside the United States and Canada, through its Merck for Mothers initiative, have announced the completion of CHAMPION (Carbetocin Haemorrhage Prevention), a global clinical trial conducted by the Human Reproduction Program (HRP) at the World Health Organization (WHO). The CHAMPION trial is studying whether Ferring’s investigational proprietary heat-stable formulation of carbetocin could offer a new solution to prevent excessive bleeding after childbirth (postpartum hemorrhage or PPH). Involving nearly 30,000 women in 10 countries, it is the largest clinical trial ever conducted in PPH. These 10 countries include Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the United Kingdom.

Kite, a Gilead Company, and Sangamo Therapeutics Announce Collaboration to Develop Next-Generation Engineered Cell Therapies for the Treatment of Cancer

February 22, 2018

Kite, a Gilead Company, and Sangamo Therapeutics, Inc. have announced that the companies have entered into a worldwide collaboration using Sangamo’s zinc finger nuclease (ZFN) technology platform for the development of next-generation ex vivo cell therapies in oncology. Kite will use Sangamo’s ZFN technology to modify genes to develop next-generation cell therapies for autologous and allogeneic use in treating different cancers.

 

Novo Nordisk successfully completes the first phase 3a trial, PIONEER 1, with oral semaglutide

February 22, 2018

Novo Nordisk has announced the headline results from PIONEER 1, the first phase 3a trial with oral semaglutide for treatment of adults with type 2 diabetes. Oral semaglutide is a new GLP-1 analogue taken once daily as a tablet. The global 26-week trial investigated the efficacy and safety of 3, 7 and 14 mg oral semaglutide compared with placebo in 703 people with type 2 diabetes. The trial achieved its primary objective according to the primary statistical principle by demonstrating significant and superior improvements in HbA1c (long-term blood sugar) for all three doses of oral semaglutide compared to placebo.

LYNPARZA® (olaparib) Receives Positive EU CHMP Opinion in Platinum-Sensitive Relapsed Ovarian Cancer

February 23, 2018

AstraZeneca and Merck, known as MSD outside the United States and Canada, have announced that CHMP of the European Medicines Agency has adopted a positive opinion, recommending a marketing authorization of LYNPARZA® (olaparib) tablets (300 mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy. LYNPARZA is recommended for treatment in this setting regardless of patients’ BRCA mutation status.

KemPharm Announces FDA Approval of Apadaz™ (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain

February 23, 2018

KemPharm, Inc., a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced that the U.S. FDA approved its New Drug Application (NDA) for Apadaz™ for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Apadaz is an immediate release (IR) combination of KemPharm’s prodrug, benzhydrocodone, and acetaminophen (APAP).

US FDA approves Imfinzi for unresectable Stage III non-small cell lung cancer

February 19, 2018

AstraZeneca and MedImmune, its global biologics research and development arm, have announced that the US FDA has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).

Top Pharma News of the Week last edit: 2018-02-26T20:31:01+00:00 da Luca

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