Search Results for “FDA” – Page 184

Biogen and Alkermes Announce License and Collaboration Agreement to Develop and Commercialize ALKS 8700 for the Treatment of Multiple Sclerosis

Biogen (Nasdaq:BIIB) and Alkermes plc (Nasdaq:ALKS) today announced that they have entered into a global license and collaboration agreement to develop and commercialize ALKS 8700, a novel, oral, monomethyl fumarate (MMF) small drug molecule in Phase 3 development for the treatment of relapsing forms of multiple sclerosis (MS).

Source: businesswire
507
November 29, 2017

Bay Area’s Medeor Therapeutics Bags $57M

Medeor Therapeutics announced it had closed on an oversubscribed Series B financing worth $57 million. The round was led by RA Capital Management. New investors included Sofinnova Ventures and 6 Dimensions Capital. They were joined by existing investors Vivo Capital and WuXi Healthcare Ventures.

Source: Biospace
618
November 28, 2017

cellular immunotherapies Market Views Series

European Commission Approves TREMFYA® (guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis in the European Union

Janssen-Cilag International NV announced that the European Commission (EC) has approved TREMFYA® (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Guselkumab is the first biologic that selectively blocks interleukin (IL)-23, a key driver of the immune inflammatory response in psoriasis.

Source: Prnewswire
460
November 27, 2017

interleukin Market Views plaque psoriasis TREMFYA

China Food and Drug Administration Approves Gilead’s Sovaldi® (Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Infection

Gilead Sciences, Inc. (NASDAQ: GILD) announced that the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.

Source: Gilead
776
November 27, 2017

CFDA Gilead Sciences HCV New Approvals Sovaldi®

Pfizer and Genentech Duke it Out in Court Over Herceptin Biosimilar Patents

On Friday, November 17, Genentech, a Roche company, sued Pfizer in a federal court in Wilmington, Delaware, over Pfizer’s biosimilar for Genentech’s Herceptin. Genentech is claiming that Pfizer’s proposed biosimilar infringes 40 of its patents. Genentech also is demanding compensation for lost sales if Pfizer launches its copycat version before the Herceptin patents expire.

Source: Biospace
644
November 24, 2017

biosimilar Company Insight FDA Genentech herceptin Pfizer Roche

Building on impressive data, Novo Nordisk maps big PhIII obesity program for blockbuster hopeful semaglutide

Encouraged by evidence of the impact that its diabetes drug semaglutide can have on obesity, with patients shedding an average of 16% of their weight in a mid-stage study, top researchers at Novo Nordisk today unveiled an ambitious late-stage strategy to make their mark in a tough, but potentially blockbuster market.

Source: endpts
563
November 22, 2017

Company Insight Novo Nordisk semaglutide

Maintaining sufficient vitamin D levels may help to prevent rheumatoid arthritis

Maintaining sufficient vitamin D levels may help to prevent the onset of inflammatory diseases like rheumatoid arthritis, research led by the University of Birmingham has discovered.

Source: medicalxpress
583
November 21, 2017

inflammatory diseases rheumatoid arthritis vitamin D

Ddu College-China’s Import and Export Market Report of Respiratory System Drugs

Respiratory system drugs is a term used to describe a wide variety of medicines used to relieve, treat, or prevent respiratory diseases such as asthma, chronic bronchitis, chronic obstructive pulmonary disease (COPD), or pneumonia. Today, Ddu, the leading global pharmaceutical & medical device B2B online platform, will share China’s Import and Export Market Report of Respiratory System Drugs with you.

Source: Ddu
1,315
November 17, 2017

asthma COPD Ddu College pneumonia respiratory

Clinical trial shows treatment is ‘transformative’ for babies with spinal muscular atrophy

Infants with the most severe form of spinal muscular atrophy (SMA) were more likely to show gains in motor function and were 47 percent more likely to survive without permanent assisted ventilation support when treated with a new medication, according to a study published today in the New England Journal of Medicine. The drug, nusinersen, performed so well that the study was stopped early and the treatment was approved shortly thereafter by the U.S. Food and Drug Administration (FDA) for all patients with this progressive neuromuscular disorder.

Source: sciencedaily
453
November 17, 2017

Market Views neuromuscular disorder SMA

Celgene Corporation and bluebird bio Announce bb2121 Anti-BCMA CAR-T Cell Therapy Has Been Granted Breakthrough Therapy Designation

Celgene Corporation and bluebird bio, Inc. announced that bb2121, a chimeric antigen receptor T-cell (CAR-T) therapy targeting b-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) eligibility by the European Medicines Agency (EMA).

Source: ansa.it
590
November 17, 2017

BTD CAR-T therapy Company Insight

Biogen and Alkermes Announce License and Collaboration Agreement to Develop and Commercialize ALKS 8700 for the Treatment of Multiple Sclerosis

Bay Area’s Medeor Therapeutics Bags $57M

European Commission Approves TREMFYA® (guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis in the European Union

China Food and Drug Administration Approves Gilead’s Sovaldi® (Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Infection

Pfizer and Genentech Duke it Out in Court Over Herceptin Biosimilar Patents

Building on impressive data, Novo Nordisk maps big PhIII obesity program for blockbuster hopeful semaglutide

Maintaining sufficient vitamin D levels may help to prevent rheumatoid arthritis

Ddu College-China’s Import and Export Market Report of Respiratory System Drugs

Clinical trial shows treatment is ‘transformative’ for babies with spinal muscular atrophy

Celgene Corporation and bluebird bio Announce bb2121 Anti-BCMA CAR-T Cell Therapy Has Been Granted Breakthrough Therapy Designation

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