Shire Reports Regulatory Milestones for Investigational Hereditary Angioedema (HAE) Treatment Lanadelumab

The European Medicines Agency (EMA) validates Shire’s Marketing Authorization Application for investigational Hereditary Angioedema (HAE) treatment lanadelumab. Validation signals EMA has sufficient data to begin review (under accelerated assessment) Health Canada has accepted Shire’s New Drug Submission (NDS) for lanadelumab under

Final results from landmark DYNAGITO® trial published in The Lancet Respiratory Medicine (1)

Results enhance existing evidence base showing Spiolto® Respimat® improves symptom reduction and quality of life over Spiriva® Respimat®2,3,4,5,6  Ingelheim, Germany, 29 March 2018 – Boehringer Ingelheim today announced data from the landmark 52-week DYNAGITO® trial which show that in people with COPD (chronic obstructive pulmonary

Marketing Application for Pegvaliase MAA for Treatment of Phenylketonuria (PKU)

FDA PDUFA Action Date for Pegvaliase is May 25, 2018 SAN RAFAEL, Calif., March 28, 2018 /PRNewswire/ — BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that the European Medicines Agency (EMA) has accepted BioMarin’s submission of a Marketing Authorization Application (MAA) for pegvaliase,

GSK reaches agreement with Novartis to acquire full ownership of Consumer Healthcare Business

Agreement with Novartis to buyout Novartis’ 36.5% stake in the Consumer Healthcare Joint Venture for $13 billion (£9.2 billion)  Proposed transaction addresses one of the Group’s stated key capital allocation priorities, supporting efforts to improve performance and capital planning for

Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer

TOKYO and BOTHELL, Wash., – March 26, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) and Seattle Genetics, Inc. (NASDAQ: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation

Akebia Therapeutics Announces Pricing of Public Offering of Common Stock

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Mar. 23, 2018– Akebia Therapeutics, Inc. (Nasdaq:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), today announced the pricing of an underwritten public offering of 8,500,000 shares of

District Court Issues Ruling Finding Adderall XR® Patents Infringed

Cambridge, Mass., USA – March 23, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG) announces that its subsidiary, Shire Development LLC, welcomes yesterday’s favorable ruling against Abhai LLC in connection with their Abbreviated New Drug Application (ANDA) for a generic version

Agios Announces First Patient Dosed with MAT2A Inhibitor AG-270 in Phase 1 Study in Patients with Advanced Solid Tumors or Lymphoma with an MTAP Deletion

MTAP Deletion Present in Approximately 15 Percent of All Cancers CAMBRIDGE, Mass., March 19, 2018 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced dosing of the first patient

U.S. FDA Grants Priority Review for a Supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) in Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)

sNDA Seeks to Expand the Indication of XTANDI to include Men with Non-metastatic CRPC NEW YORK and TOKYO, March 19, 2018 Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that

Alexion Announces Positive Top-Line Results Showing Successful Phase 3 Clinical Study Of ALXN1210 In Complement Inhibitor Treatment-Naïve Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

March 15, 2018 — ALXN1210 Achieved Non-Inferiority to Soliris ® (Eculizumab) on Co-Primary Endpoints of Transfusion Avoidance and Lactate Dehydrogenase Normalization, and All Four Key Secondary Endpoints — — Safety Profile of ALXN1210 Consistent with That Seen for Soliris ® — — Regulatory Submissions

Supernus Announces Pricing of $350 Million Private Offering of 0.625% Convertible Senior Notes

Mar 15, 2018 ROCKVILLE, Md., March 15, 2018 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) (the “Company”), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, announced today the pricing of its private offering of $350

Vertex Initiates Phase 3 Study of VX-659, Tezacaftor and Ivacaftor as a Triple Combination Regimen for People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation

-Global Phase 3 study to enroll approximately 100 patients with the most common genetic form of the disease- -Phase 2 data showed mean absolute improvement in ppFEV1 of 9.7 percentage points when VX-659 was added in people with CF who have