Company News

AstraZeneca granted Fast Track Designation in the US for the development of Farxiga

  • Posted on: 20 July 2020
  • By: PharmaTutor News

AstraZeneca has been granted Fast Track Designation in the US for the development of Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) or cardiovascular (CV) death in adults following an acute myocardial infarction (MI) or heart attack.

Roche’s OCREVUS (ocrelizumab) shorter 2-hour infusion time approved in Europe

  • Posted on: 29 May 2020
  • By: PharmaTutor News

Roche announced European Medicines Agency (EMA) approval of a new, shorter two-hour OCREVUS® (ocrelizumab) infusion time, dosed twice yearly, for relapsing or primary progressive multiple sclerosis (MS). The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Cipla receives final approval for generic version of Migranal®

  • Posted on: 22 May 2020
  • By: PharmaTutor News

Cipla Limited announced that it has received final approval for its Abbreviated New Drug Application (“ANDA”) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the United States Food and Drug Administration (U.S. FDA) with a Competitive Generic Therapy (“CGT”) designation. Cipla is the “first approved applicant” for such CGT and, is therefore, eligible for 180 days of CGT exclusivity which will begin to run from the commercial marketing of Cipla’s product. This 180-day CGT exclusivity will not block the commercialization of the existing approvals of Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL.

AMAG Pharmaceuticals completes sale of its rights to Intrarosa® to Millicent Pharma for up to $125 Million

  • Posted on: 22 May 2020
  • By: PharmaTutor News

AMAG Pharmaceuticals, Inc announced it has completed the sale of its rights to Intrarosa® (prasterone) to Millicent Pharma Limited, a global pharmaceutical company formed by the Millicent Pharma management team and The Carlyle Group in 2018 that specializes in women’s health and menopause-related conditions, for up to $125 million, including upfront fixed consideration of $20 million and contingent, sales-based milestone payments of up to $105 million.

Biocon Biologics Receives EU GMP Certification for Multiple Biosimilars Manufacturing Facilities

  • Posted on: 20 May 2020
  • By: PharmaTutor News

Asia’s premier biopharmaceuticals company, announced today that its subsidiary Biocon Biologics India Ltd. has received the Certificate of GMP compliance from EMA for multiple Biologics Drug Substance (DS) and Drug Product (DP) manufacturing facilities at Biocon Park, Bengaluru.

US based Sorrento Therapeutics claims breakthrough against COVID-19, shares jumps around 244 percent

  • Posted on: 17 May 2020
  • By: PharmaTutor News

San Diego based Sorrento Therapeutics claims that its anti-SARS-CoV-2 antibody, STI-1499, demonstrated 100% inhibition of SARS-CoV-2 virus infection in an in vitro virus infection experiment at a very low antibody concentration which lead to jumps in stocks around 244%.

18 approved and investigational Pfizer medicines to be showcased

  • Posted on: 14 May 2020
  • By: PharmaTutor News

Pfizer Inc announced that new data from clinical trials of 18 approved and investigational medicines will be presented virtually at the ASCO20 Virtual Scientific Program, from May 29-May 31. The data that will be presented build on Pfizer’s strong track record in oncology by providing new insights in areas like breast, colorectal and genitourinary cancers, which include bladder, prostate, and kidney cancer. Data from Pfizer’s early stage pipeline, including a novel anti-HER2 antibody-drug conjugate, will also be presented as Pfizer aims to transform the cancer treatment landscape well into the future.

Glenmark introduces advance inhaler therapy for COPD in India

  • Posted on: 12 May 2020
  • By: PharmaTutor News

Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led global integrated pharmaceutical company, today announced the launch of a Single Inhaler Triple Therapy AIRZ-FF - a combination of two bronchodilators, Glycopyrronium & Formoterol and the inhalation corticosteroid Fluticasone propionate, for Chronic Obstructive Pulmonary Disease (COPD).

Lupin’s Pithampur Facilities Complete Successful UK MHRA Inspection

  • Posted on: 9 May 2020
  • By: PharmaTutor News

Pharma major Lupin Limited (Lupin) announced the successful close out of the inspection carried out by the Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory agency of the United Kingdom (UK), at its three manufacturing units in Pithampur (India). The inspection for the three units at Pithampur (Unit I, Unit II and Unit III) was conducted in January 2020.