Pharma feed

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Novartis AG
FirstWord Pharma· 07 Dec 2019

Swiss approve insurance cover for Novartis, Gilead cell therapies

The Swiss government on Friday authorized health insurance coverage for Novartis' Kymriah and Gilead Sciences' Yescarta, both of which are CAR-T cell therapies, as reported by the Financial Post. "The contract between hospitals and health insurers will be approved until the end of 2020, granting the affected patients immediate access to these therapies," the government said.

  • Novartis AG
  • Procurement and Sales
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Novartis AG
FirstWord Pharma· 07 Dec 2019

Swiss approve insurance cover for Novartis, Gilead cell therapies

The Swiss government on Friday authorized health insurance coverage for Novartis' Kymriah and Gilead Sciences' Yescarta, both of which are CAR-T cell therapies, as reported by the Financial Post. "The contract between hospitals and health insurers will be approved until the end of 2020, granting the affected patients immediate access to these therapies," the government said.

  • Novartis AG
  • Procurement and Sales
  • News Articles
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Johnson & Johnson
Seeking Alpha· 07 Dec 2019

J&J CAR T nabs accelerated review status in U.S. for multiple myeloma

The FDA designates Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceuticals' CAR T candidate JNJ-682284528 (JNJ-4528) a Breakthrough Therapy for the treatment of relapsed/refractory multiple myeloma.

  • Johnson & Johnson
  • Janssen Pharmaceuticals Inc
  • Regulatory and Legal
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Bristol-Myers Squibb Co
Seeking Alpha· 07 Dec 2019

Bristol-Myers and bluebird bio's CAR T successful in mid-stage MM study

Bluebird bio (NASDAQ:BLUE) and licensee Bristol-Myers Squibb (NYSE:BMY) announce positive topline results from a Phase 2 clinical trial, KarMMa, evaluating CAR T therapy idecabtagene vicleucel (ide-cel) (bb2121) in treatment-resistant multiple myeloma (MM) patients. The study met the primary and key secondary endpoints.

  • Bristol-Myers Squibb Co
  • Clinical Trials
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Twitter· 07 Dec 2019

#Amgen is proud to support this weekend’s @miles4migraine Walk/Run in Los Angeles. We’re dedicated to serving people living with #migraine. Attending the race? Visit our booth to learn more about our research. Race details here: https://t.co/RoCv0C7d1G

Miles For Migraine
Thank You Committee We know some of you cannot get up early, have chronic migraine, or are fearful of having an attack in public. But we still need you to come to the event and ...
  • Amgen, Inc.
  • Events
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  • Twitter
Twitter· 07 Dec 2019

The U.S. FDA has approved #Amgen's 4th biosimilar which represents an important milestone for our biosimilar portfolio. Press release here: https://t.co/zqcKWXpbT1 $AMGN

FDA Approves Amgen's AVSOLA™ (infliximab-axxq), For The Same Indications As Remicade® (infliximab)
THOUSAND OAKS, Calif.,Dec. 6, 2019/PRNewswire/ --Amgen(NASDAQ:AMGN) today announced that theU.S. Food and Drug Administration(FDA) has approved AVSOLA™ (infliximab-axxq) for all...
  • Amgen, Inc.
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Amgen, Inc.
The Center for Biosimilars· 07 Dec 2019

FDA Approves Amgen's Infliximab Biosimilar, Avsola

inf inf The FDA has approved Amgen’s infliximab biosimilar, Avsola (infliximab-axxq), referencing Remicade.

  • Amgen, Inc.
  • Regulatory and Legal
  • News Articles
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Merck & Co., Inc.
Bioprocessintl· 07 Dec 2019

Merck plans investment to support rotavirus vaccine - Bioprocess Insider

The investment at the facility in Wilson, North Carolina comes on the back of several expansion across Merck & Co’s vaccine manufacturing network. Merck (known as MSD outside of North America) announced just five months ago plans to invest $680 million (€613 million) to ramp up its vaccine production capabilities in North Carolina to support human papillomavirus (HPV) vaccines Gardasil and Gardasil 9.

  • Merck & Co., Inc.
  • Business Expansion
  • Company Websites
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Bayer AG
Obroncology· 07 Dec 2019

Bayer Reaches Agreement To Postpone More Glyphosate Lawsuits For Settlement Talks – OBR

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  • Bayer AG
  • Regulatory and Legal
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Takeda Pharmaceutical Co Ltd
Pharmasalmanac· 07 Dec 2019

Takeda and Enzyre to Develop Diagnostic Device Allowing Hemophilia Patients to Determine their Coagulation Status at Home

NIJMEGEN, Netherlands /PRNewswire/ -- Enzyre, which is developing breakthrough ambulant diagnostic technology for coagulation testing, today announced that it has entered into a research collaboration agreement with Takeda Pharmaceutical Company Limited (Takeda) to develop a diagnostic device that will enable hemophilia patients to determine their coagulation status at home.

  • Takeda Pharmaceutical Co Ltd
  • PHARMA’S ALMANAC
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Alexion Pharmaceuticals Inc
Slater Sentinel· 07 Dec 2019

2,995 Shares in Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) Purchased by First Allied Advisory Services Inc.

First Allied Advisory Services Inc. acquired a new position in shares of Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) during the 3rd quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission (SEC).

  • Alexion Pharmaceuticals Inc
  • First Allied Advisory Services Inc
  • M&A Activities
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Johnson & Johnson
Pharmiweb· 07 Dec 2019

Janssen to Acquire Investigational Bermekimab from XBiotech

HORSHAM, Pa., Dec. 7, 2019 /PRNewswire/ -- Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, announced today that it has entered a definitive agreement to acquire all rights to the investigational compound bermekimab from XBiotech Inc.

  • Johnson & Johnson
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AstraZeneca PLC
Astrazeneca· 07 Dec 2019

Calquence significantly prolonged the time patients lived without disease progression or death in previously untreated chronic lymphocytic leukaemia

These findings, along with previously reported data from the Phase III ASCEND trial in relapsed or refractory CLL, support the recent approvals of Calquence by the US FDA and the Australian Therapeutic Goods Administration for

  • AstraZeneca PLC
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Bristol-Myers Squibb Co
FirstWord Pharma· 06 Dec 2019

Bristol-Myers Squibb and Acceleron Pharma Provide Update on FDA Advisory Committee for Reblozyl (luspatercept-aamt)

The agency has informed Bristol-Myers Squibb that the original Prescription Drug User Fee Act (PDUFA), or target action, date of April 4, 2020 for its supplemental Biologics License Application ("sBLA") for Reblozyl will remain, without the requirement for an ODAC review.

  • Bristol-Myers Squibb Co
  • Acceleron Pharma Inc
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Bristol-Myers Squibb Co
FirstWord Pharma· 06 Dec 2019

Bristol-Myers Squibb and Acceleron Pharma Provide Update on FDA Advisory Committee for Reblozyl (luspatercept-aamt)

The agency has informed Bristol-Myers Squibb that the original Prescription Drug User Fee Act (PDUFA), or target action, date of April 4, 2020 for its supplemental Biologics License Application ("sBLA") for Reblozyl will remain, without the requirement for an ODAC review.

  • Bristol-Myers Squibb Co
  • Acceleron Pharma Inc
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  • Alexion Pharmaceuticals Inc
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Ad Council
Ad Council· 06 Dec 2019

The Ad Council’s 66th Annual Public Service Award Dinner Celebrates the Power of Purpose

Hosted by Ellie Kemper, the event raised over $5.8 million for national social good campaigns, honoring Johnson & Johnson Chairman and CEO Alex Gorsky NEW YORK, NY, December 6, 2019 – Last night, the Ad Council, America’s leading organization dedicated to using communications to drive social change, held its Annual Public Service Award Dinner.

  • Ad Council
  • Johnson & Johnson
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U.S. Food and Drug Administration
Reuters· 06 Dec 2019

FDA approves Amgen's biosimilar to J&J's rheumatoid arthritis drug

Dec 6 (Reuters) - The U.S. Food and Drug Administration on Friday approved Amgen Inc’s biosimilar copy of Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade, according to the regulator’s website. The biosimilar, Avsola, has the same chemical components, dosage form and strength as Remicade and would treat a range of autoimmune disorders.

  • U.S. Food and Drug Administration
  • Amgen, Inc.
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  • Amgen, Inc.
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Novartis AG
Novartis· 06 Dec 2019

Legal Business Partner

Job Description 750 million! That’s how many lives our products touch.

  • Novartis AG
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  • The University of Chicago Medicine
  • AbbVie Inc
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Alexion Pharmaceuticals Inc
FirstWord Pharma· 06 Dec 2019

Alexion turns down hedge fund's push for "proactive sale"

Alexion Pharmaceuticals stated Friday that its board has unanimously decided against a recommendation by hedge fund Elliott Management to immediately launch a proactive sale, saying such a move would not be in the best interest of shareholders at this time.

  • Alexion Pharmaceuticals Inc
  • Financial and Business Performance
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Johnson & Johnson
Seeking Alpha· 06 Dec 2019

FDA OKs Amgen's Remicade biosimilar

The FDA approves Amgen's (AMGN +0.1% ) Avsola (infliximab-axxq), its biosimilar to Johnson & Johnson's (JNJ +0.9% ) autoimmune disease med Remicade. The TNF inhibitor accounted for over 10% of J&J's Q3 drug sales.

  • Johnson & Johnson
  • Amgen, Inc.
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  • UCB SA
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  • Amgen, Inc.
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