Industry news

21 February 2018

Evofem Biosciences Receives Fast Track Designation for Amphora for Prevention of Chlamydia

Evofem Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company"), a biotechnology company developing innovative products to fill women's unmet healthcare needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Amphora® (L-lactic acid, citric acid, and potassium bitartrate) vaginal gel for the prevention of urogenital chlamydia in women.

Remicade biosims from Pfizer, Merck unlikely to turn the tide in 2018: analyst

Eric Sagonowsky / FiercePharma

Pfizer hasn't gained much market share with Inflectra, its biosimilar of Johnson & Johnson's Remicade, since its U.S. launch back in 2016. The company's CEO Ian Read recently said Inflectra is picking up increased commercial coverage, but an analyst figures the biosimilar's challenges aren't likely to let up this year. 

20 February 2018

Evofem Biosciences Completes Enrollment of Phase 3 Contraceptive Trial of Amphora Ahead of Schedule

Evofem Biosciences, Inc., (NASDAQ: EVFM), a biotechnology company developing innovative products to fill women's unmet healthcare needs, announced early completion of enrollment in its Phase 3 clinical trial evaluating Amphora® (L-lactic acid, citric acid, and potassium bitartrate) vaginal gel for the prevention of pregnancy. Trial data is expected in the first quarter of 2019.

Using stem cells to generate an immune attack against cancer

Arlene Weintraub / FierceBiotech

Induced pluripotent stem cells (iPSCs) have the power to transform into any cell in the body, making them a prime candidate for regenerative medicine. But can they also teach the immune system to recognize and attack cancer?

Russians develop advanced multiple myeloma drug candidate

Marchmont Innovation News

Hemopharm, a Russian biotech company, is developing a drug candidate that might help multiple myeloma patients. The new Hemopharm solution is expected to evolve to be such a drug. No direct competition has been reported so far in the global pharmaceutical market. The drug candidate is a humanized antibody with purportedly outstanding anti-tumor activity and low toxicity with proven in vivo efficacy.

Ferring Pharmaceuticals will launch a new biotech centre in Switzerland

GMP News

Ferring Pharmaceuticals announced that it is expanding its capabilities in biologics through a new biotech centre which will be installed at the company’s existing headquarters and manufacturing site in Saint-Prex, Switzerland.

Pfizer taps BC for real-world cardiovascular research drive

Nick Paul Taylor / FierceBiotech

Pfizer has teamed up with BC Platforms to generate real-world evidence on cardiovascular diseases. The collaboration will leverage BC’s technology and Finnish health records to better understand atrial fibrillation patients.

Pharma and AI: Help doctors with AI assistants but don’t try to replace them

Beth Snyder Bulik / FiercePharma

Dr. Robot gets a thumbs down from patients, according to new research from Syneos Health. Despite tech and investor enthusiasm, along with media headlines highlighting artificial intelligence in healthcare, patients are adamant that artificial intelligence should not replace doctors.

Pharma Looks to Change the Healthcare Cost Conversation

Jill Wechsler / BioPharm Intartnational

Amidst the continuing clamor for government action to curb prescription drug prices, a more collaborative effort aims to broaden the debate to consider the full range of healthcare services and rates that affect spending in this area. The National Pharmaceutical Council (NPC), a pharma-funded research organization, is partnering with the independent journal Health Affairs to examine the root causes of rising healthcare outlays in the United States. This two-year program will support academic and professional research projects and commentaries to be published and disseminated online by the journal.

FDA Releases Guidance on Systemic Antibacterial Drugs

BioPharm International

FDA published guidance on the development, analysis, and presentation of microbiology data during the development of antibacterial drugs. The agency discusses the overall microbiology development program it says is needed to support clinical development and approval of antibacterial drugs administered systemically. The guidance also addresses microbiology data collected after drug approval.