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Pfizer meningitis drug gains European approval for young patients

American Pharmacy News Reports | Jun 13, 2017
Young people can be misled by meningococcal disease symptoms, which can resemble the flu.

Trumenba, Pfizer’s branded vaccine against certain forms of meningococcal disease, officially won approval from the European Commission for patients aged 10 years and up, representing progress for protection in the young adult demographic. Read More »

Pfizer furthers partnership for affordable contraception in developing countries

Carol Ostrow | Jun 10, 2017
The all-in-one injection was distributed to 20 developing nations by the end of 2016.

Mutual recommitment to a partnership between Pfizer and two U.S. foundations has successfully ensured continued access to Pfizer’s Sayana Press contraceptive for women in the world’s poorest nations. Read More »

Pfizer, Celltrion present data on Inflectra at 12th ECCO Congress

American Pharmacy News Reports | Jun 9, 2017
Pfizer is in the midst of an ongoing 54-week study of Inflectra.

Pfizer Inc. and Celltrion Healthcare presented data at the 12th Congress of the European Chron’s and Colitis Organisation showing Inflectra (infliximab CT-P13) delivers similar efficacy and safety as Remicade (infliximab) for treating Chron’s Disease. Read More »

Pfizer plans Phase 3 study of Clostridium difficile vaccine

American Pharmacy News Reports | Jun 9, 2017
Clostridium difficile, a spore-forming pathogen, often targets people with altered gut microbial flora.

Pfizer Inc. recently shared positive data from its Phase 2 study examining Clostridium difficile (C. difficile) vaccine candidate, PF-06425090, a product created to help prevent C. difficile infection (CDI), which can include life-threatening diarrhea and pseudomembranous colitis. Read More »

Pfizer's Xeljanz receives positive opinion from European committee

American Pharmacy News Reports | Jun 9, 2017
More than 2.9 million people are currently living with moderate to severe rheumatoid arthritis in Europe.

Pfizer Inc. recently announced that its Xeljanz drug for treating moderate to severe active rheumatoid arthritis (RA) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Read More »

Bavencio gains FDA approval for intravenous use

American Pharmacy News Reports | Jun 5, 2017
Bavencio was approved by the FDA for intravenous use.

Pfizer Inc. and EMD Serono, Merck KHaA’s biopharmaceutical arm in the United States and Canada, recently announced that Bavencio was approved by the Food and Drug Administration for intravenous use. Read More »

BAVENCIO receives FDA approval for advanced bladder cancer treatment

American Pharmacy News Reports | May 12, 2017
Advanced UC has a high recurrence rate, and overall the five-year survival rate is approximately 5 percent.

EMD Serono has received Food and Drug Administration approval of BAVENCIO (avelumab) as a treatment for locally advanced or metastatic urothelial carcinoma. Read More »

Pfizer's inotuzumab ozogamicin accepted for priority review

American Pharmacy News Reports | May 8, 2017
The FDA had granted the drug Breakthrough Therapy designation in October 2015.

The U.S. Food and Drug Administration has accepted Pfizer's Biologics License Application for inotuzumab ozogamicin. Read More »

Pfizer releases results from ORAL Strategy study of Xeljanz

American Pharmacy News Reports | May 6, 2017
The study found that XELJANZ 5mg plus MTX demonstrated non-inferiority vs. Humira plus MTX.

Pfizer Inc. recently released top-line results for ORAL Strategy, a Phase 3B/4 study of XELJANZ (tofacitinib citrate) 5mg twice daily in the treatment of moderate to severe rheumatoid arthritis. Read More »

Collaboration to develop biomarker technology

American Pharmacy News Reports | Apr 25, 2017
A biomarker is a molecule that allows researchers to non-invasively diagnose and monitor the progression of a disease or condition.

A collaboration to develop biomarker technology was announced by Bristol-Myers Squibb Co. and Nordic Bioscience last week. Read More »

FDA grants priority review to carcinoma drug

American Pharmacy News Reports | Apr 24, 2017
Avelumab, an investigational, fully human anti-PD-L1 antibody, is a potential treatment for patients with locally advanced or metastatic urothelial carcinoma.

EMD Serono, the biopharmaceutical business of Merck KGaA and Pfizer Inc., recently announced that the Biologics License Application (BLA) for their avelumab drug was accepted for Priority Review by the U.S. Food and Drug Administration (FDA). Read More »

Pfizer, PSI partner to treat hypertension in Southeast Asia

American Pharmacy News Reports | Apr 21, 2017
The collaboration, dubbed Health Communities, will work to develop sustainable and scalable treatment models.

Pfizer Inc. and nonprofit Population Services International recently announced a $1 million collaboration that will make it easier for people with hypertension in Myanmar and Vietnam to access medicine and treatment. Read More »

FDA grants priority review for Bristol-Myers' Opdivo sBLA

American Pharmacy News Reports | Apr 10, 2017
This milestone illustrates Bristol-Myers Squibb’s continued efforts to evaluate the potential of Immuno-Oncology in a broad range of cancers.

The U.S. Food and Drug Administration (FDA) has granted Bristol-Myers Squibb Co. a priority review for the company’s Opdivo Biologics License Application. Read More »

FDA approves application for breast cancer drug from Pfizer

American Pharmacy News Reports | Apr 9, 2017
The approval comes after a Phase 3 study that evaluated Ibrance first-line therapy in combination with letrozole.

Pfizer Inc.'s supplemental New Drug Application (sNDA) for Ibrance, its first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, has been approved by the U.S. Food and Drug Administration. Read More »

Bristol-Myers and Incyte to launch Phase 3 studies of drug combination

Mark Iandolo | Apr 6, 2017

Bristol-Myers Squibb Co. and Incyte Corp. have agreed to advance their clinical development program. Read More »

District Court in Delaware invalidates four Ampyra patents

American Pharmacy News Reports | Apr 4, 2017
Acorda Therapeutics is appealing the case.

Acorda Therapeutics Inc. recently announced that the United States District Court for the District of Delaware invalidated four of its patents related to Ampyra extended release tablets. Read More »

Pfizer's TRUMENBA moves closer to European approval

American Pharmacy News Reports | Mar 29, 2017
Data showed TRUMENBA produced a protective serum antibody response to meningococcal group B strains.

Pfizer Inc.'s meningococcal group B vaccine TRUMENBA has received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use. Read More »

European Commission approves XELJANZ for rheumatoid arthritis

American Pharmacy News Reports | Mar 29, 2017
The EC approval was based in part on the results of the Phase III Oral Rheumatoid Arthritis Trials.

XELJANZ (tofacitinib citrate) has been approved by the European Commission in mono or combination therapy for rheumatoid arthritis. Read More »

Bavencio treatment for Merkel cell carcinoma patients gains FDA approval

American Pharmacy News Reports | Mar 28, 2017
The FDA’s approval comes after the conclusion of the Javelin Markel 200 trial.

EMD Serano, the biopharmaceutical business of Merck KGaA, and Pfizer Inc. recently received approval from the U.S. Food and Drug Administration to market Bavencio Injection 20 mg/mL for intravenous use. Read More »

Auryxia by Keryx has been picked up by nation's largest Medicare Part D sponsor

American Pharmacy News Reports | Mar 27, 2017
Auryxia is approved in the U.S. for controlling serum phosphorous levels in patients suffering from chronic kidney disease on dialysis.

Keryx Pharmaceuticals Inc.'s largest Medicare Part D plan sponsor in the United States has added the company’s Auryxia drug to its Medicare Part D plan formularies. Read More »

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Trending

Brianna Allen, Senior Director of Public Affairs at PhRMA

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Dan DeNeui, CEO of FarmaKeio

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Luke Gale, Revenue Cycle Editor, HealthLeaders Media

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Lenora S. Newsome PD Chairperson

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