Friday , February 15 2019

Specialty Pharma Journal Specialty, Precision & Technology

Breaking News

Bayer Acquires Full Rights to Loxo Oncology’s Vitrakvi and LOXO-195
FDA Grants Priority Review to Merck’s sBLA for Keytruda Plus Inlyta as First-Line Treatment for Advanced Renal Cell Carcinoma
FDA Announces Breakthrough Therapy Designation to CymaBay’s Seladelpar for Treatment of Primary Biliary Cholangitis
Bayer’s Investigational Darolutamide Plus ADT Significantly Extends Metastasis-Free Survival in Phase 3 Study of Non-Metastatic Castration-Resistant Prostate Cancer
Opdivo Plus Yervoy Shows Response in Pre-Treated Patients with Metastatic Castration-Resistant Prostate Cancer
Novartis Enters 10-Target Antibody Discovery Deal with AbCellera
Sarepta Announces FDA Acceptance of Golodirsen NDA for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53
Janssen Announces Preliminary Results from Phase 2 Study in Adults with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Pathway Defects
Ultragenyx and Kyowa Kirin Announce Positive Results for Crysvita from Phase 3 Study in Children with X-linked Hypophosphatemia
Merck Increases Focus on Advanced Prostate Cancer, Expanding Immuno-Oncology Program with Three New Phase 3 Trials

Bayer Acquires Full Rights to Loxo Oncology’s Vitrakvi and LOXO-195

WHIPPANY, N.J., Feb. 15, 2019 /PRNewswire/ — Bayer has exercised its option, un…
FDA Grants Priority Review to Merck’s sBLA for Keytruda Plus Inlyta as First-Line Treatment for Advanced Renal Cell Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United State…
FDA Announces Breakthrough Therapy Designation to CymaBay’s Seladelpar for Treatment of Primary Biliary Cholangitis

NEWARK, Calif., Feb. 15, 2019 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (NASDAQ: CBAY), to…
Bayer’s Investigational Darolutamide Plus ADT Significantly Extends Metastasis-Free Survival in Phase 3 Study of Non-Metastatic Castration-Resistant Prostate Cancer

WHIPPANY, N.J., Feb. 14, 2019 /PRNewswire/ — Results from the pivotal Phase III…
Opdivo Plus Yervoy Shows Response in Pre-Treated Patients with Metastatic Castration-Resistant Prostate Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today anno…

Precision Medicine

Specialty Pharmacy

Technology & Devices

Blog

The 2017 Hepatitis C Treatment Landscape

February 22, 2017 Blog

Last year, 2016, brought a whirlwind of changes and progress to the hepatitis C field, …
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Understanding the Hepatitis C Testing Process

February 15, 2017 Blog
Potential New Medication for Lymphoma

February 8, 2017 Blog

Recent Posts

FDA Expands Approval of Genmab, Novartis’ Arzerra in CLL

August 31, 2016 FDA News, Oncology

Copenhagen, Denmark; August 31, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the …

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FDA Approves Sandoz’s Erelzi, a Biosimilar to Enbrel

August 31, 2016 Autoimmune Disorders, Biosimilars, FDA News, Psoriasis

Holzkirchen, August 30, 2016 – Sandoz, a Novartis division and the global leader in biosimilars, …

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FDA Accepts CSL’s BLA for First Subcutaneous Prophylactic Therapy to Prevent HAE Attacks

August 30, 2016 FDA News, Hereditary Angioedema

KING OF PRUSSIA, Pa., Aug. 30, 2016 /PRNewswire/ — CSL Behring announced today that the …

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Rheumatoid Arthritis: Treatment Choices

August 30, 2016 Blog

Early treatment for rheumatoid arthritis, studies show, pays off for patients in terms of long-term …

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CHART-1: Largest Cardiac Regenerative Therapy Trial Brings New Insights

August 29, 2016 Specialty Pharmacy

Rome, Italy – 28 August, 2016: A therapy that uses bone-marrow stem cells to promote …

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Walgreens and Prime Therapeutics Form Strategic Alliance Aimed at Lowering Costs and Improving Outcomes

August 29, 2016 Business News, Specialty Pharmacy

Deerfield, Ill. and St. Paul, Minn. – Aug. 29, 2016 – Walgreens and Prime Therapeutics …

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CTI BioPharma’s Late-Stage Study of Lead Candidate Shows Mixed Results in Advanced Myelofibrosis

August 29, 2016 Oncology

SEATTLE, Aug. 29, 2016 /PRNewswire/ — CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) …

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Amgen Announces Positive Top-Line Results from Late-Stage Prolia Study

August 29, 2016 Osteoporosis

THOUSAND OAKS, Calif., Aug. 29, 2016 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced positive top-line …

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FDA Advises Testing for Zika Virus in all Donated Blood and Blood Components in the US

August 29, 2016 FDA News, Infectious Diseases

As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food …

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Mallinckrodt Sells its Nuclear Imaging Business to IBA Molecular for $690 Million

August 26, 2016 Business News

CHESTERFIELD, United Kingdom, Aug. 24, 2016 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a leading specialty …

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Special Report Documents Zika Virus’ Impact on the Fetal Brain

August 26, 2016 Infectious Diseases

BOSTON – In a special report released August 23 in the journal Radiology, a team …

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Fused Genes Found in Esophageal Cancer Cells Offer New Clues on Disease Mechanism

August 26, 2016 Oncology, Precision Medicine

Despite years of research, cellular mechanisms contributing to cancers like esophageal adenocarcinoma have remained elusive. …

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More Chemo Drugs Don’t Improve Treatment of Rare Bone Cancer

August 26, 2016 Oncology, Rare Diseases

Adding two chemotherapy drugs to the standard treatment for a rare bone cancer did not …

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FDA Rejects Amgen’s Next-Generation Chronic Kidney Disease Drug

August 26, 2016 FDA News, Nephrology

THOUSAND OAKS, Calif., Aug. 24, 2016 /PRNewswire/ — Amgen (Nasdaq: AMGN) today announced that the …

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Novartis’ MS Drug BAF312 Succeeds in Late-Stage Study

August 25, 2016 Multiple Sclerosis

Basel, August 25, 2016 – Novartis today announced the Phase III EXPAND study, evaluating the …

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