Bio Pharma Dive

FEBRUARY 22, 2022

Positive study results for the companies' drug Enhertu in patients whose only remaining option is chemo could open up a new treatment use, pressuring competitors Roche and SeaGen.

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Drugs 265

Pharmaceutical Technology

OCTOBER 31, 2023

Sellas will be meeting with the FDA in Q4 2023 to discuss Breakthrough Therapy Designation for SLS009 as a treatment for r/r PTCL.

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Bio Pharma Dive

JULY 12, 2021

Days after the FDA narrowed the target population for Biogen's drug, the patient advocacy group said it's urging Medicare to adopt a nationwide policy. Payers are seeking guidance, too.

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Drugs 265

Bio Pharma Dive

JULY 28, 2021

Pfizer previously predicted booster shots would be needed within a year. But the spread of the transmissible Delta variant may mean a booster is needed "a little earlier," CEO Albert Bourla said Wednesday.

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Eye on FDA

JULY 19, 2021

It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. Consider “FDA in Brief” releases as a sort of press release-lite. They generally have a more limited audience and a different format than FDA press releases.

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Vaccination Vaccine Medicine Drugs 93

BioSpace

APRIL 24, 2023

FDA Presses Pause on Another Foghorn Program 4/25/2023

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Scienmag

NOVEMBER 9, 2021

November 9, 2021 (Cambridge, MA)—In keeping with its mission and longstanding commitment to grow diversity in the ranks of published authors, the MIT Press (MITP) announces the launch of the Grant Program for Diverse Voices.

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Fierce Pharma

DECEMBER 9, 2022

Senator presses Amgen with 'final request' for information in tax probe. Fri, 12/09/2022 - 09:50.

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Scienmag

MAY 25, 2022

The press conferences will feature select abstracts that are being presented at ENDO 2022, the Endocrine Society’s annual meeting. Researchers will delve into the latest research in diabetes, obesity, thyroid and other endocrine conditions during the Endocrine Society’s ENDO 2022 news conferences June 11-14.

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Research 84

Fierce Pharma

APRIL 5, 2024

Amid ongoing drug shortages and other headline-grabbing issues that fall under the FDA’s purview, the House Committee on Oversight and Accountability is putting the agency’s commissioner Robert Cal | The April 11 hearing could be contentious, as the committee wants to “hold the commissioner accountable" for the FDA's action on drug shortages, (..)

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Drugs 95

Eye on FDA

JANUARY 12, 2022

In prior years, the agency statements under a heading called “ FDA in Brief “ These are statements that differ in format and nature from a traditional press release. Press releases are often (though not always) released in English and Spanish, while FDA in Brief statements are not. Why the plunge?

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Gene Therapy Production Gene Vaccination 73

Bio Pharma Dive

AUGUST 4, 2022

On earnings calls with investors, executives reiterated opposition to legislation advanced by Democrats that would curtail their pricing power in the U.S.

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Drugs 171

Bio Pharma Dive

MARCH 14, 2024

Pressed by lawmakers, the lobbying group is also “taking steps” to end its relationship with Wuxi-AppTec, a major contract manufacturer to the biopharmaceutical industry.

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Contract Manufacturing Manufacturing 280

Scienmag

APRIL 20, 2021

EB 2021 will feature the latest insights into COVID-19, cancer, heart disease and more Embargoed press materials are now available for the virtual Experimental Biology (EB) 2021 meeting, featuring cutting-edge multidisciplinary research from across the life sciences.

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Life Science Research Cardiology Medicine 75

Bio Pharma Dive

FEBRUARY 15, 2024

Analysts pressed Alnylam executives on the reasons for the changes to HELIOS-B, a Phase 3 study in ATTR amyloidosis with cardiomyopathy that is important to the company’s future.

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Drug Trials Trials Drugs 311

Bio Pharma Dive

FEBRUARY 7, 2022

Despite tumbling biotech valuations, however, several said they still prefer smaller-sized "bolt-on" deals to larger, potentially more disruptive, transactions.

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BioTech 365

JANUARY 21, 2021

IBA Press R IBA Press R Louvain-la-Neuve, Belgium, 21 January 2021 – IBA (Ion Beam Applications SA), the world’s leading provider of proton therapy solutions for the treatment of cancer, today provides a trading update ahead of the Company’s full-year … Continue reading →

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Scienmag

MAY 16, 2021

Handbook for Pricing & Ethical Guidelines releasing this May Credit: The MIT PRESS, 2021 The MIT Press is delighted to announce the publication of the Graphic Artists Guild Handbook, 16th Edition: Pricing & Ethical Guidelines.

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Scienmag

APRIL 26, 2021

Susan Landau’s ‘People Count’ Credit: The MIT PRESS, 2021. How do you stop a pandemic before a vaccine arrives? Contact tracing is key, the first step in a process that has proven effective: trace, test, and isolate.

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Vaccination Vaccine Allergies Engineer 77

BioTech 365

JANUARY 12, 2021

IBA Press Release – Share buyback IBA Press Release – Share buyback Immediate Release – January 12th, 2021 Louvain-la-Neuve, Belgium, January 12th, 2021 – Ion Beam Applications SA (IBA) announced today the launch of a share buyback program, effective as … Continue reading →

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Bio Pharma Dive

NOVEMBER 6, 2020

Roctavian, the biotech's hemophilia gene therapy, was turned down by the FDA in August, while an important rare disease drug is now under review.

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Gene Therapy Drugs Gene 219

Scienmag

APRIL 16, 2021

Watch live and recorded press conferences at [link] Press conferences will be held Monday, April 5, through Friday, April 16, 2021. Below is the schedule, which will be updated as needed. ALL TOPICS ARE STRICTLY EMBARGOED FOR THE DAYS AND TIMES INDICATED.

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Research 40

BioTech 365

APRIL 11, 2022

Press release Biocartis Group NV: Invitation to the Annual Shareholders’ Meeting Press release Biocartis Group NV: Invitation to the Annual Shareholders’ Meeting PRESS RELEASE: REGULATED INFORMATION 12 April 2022, 07:00 CEST Invitation to the Annual Shareholders’ Meeting Mechelen, Belgium, 12 April … Continue reading →

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Regulation 40

Scienmag

SEPTEMBER 20, 2021

— Cold Spring Harbor Laboratory Press (CSHLP) announced the release of T-Cell Memory, available on its website in hardcover and eBook formats. Cold Spring Harbor, NY. Credit: Worldwide: © Salvador Dali, Fundacio Gala-Salvador Dali (ARS) 2021. In the USA: © Salvador Dali Museum, Inc, St Petersburg, FL 2021. Cold Spring Harbor, NY.

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BioTech 365

OCTOBER 11, 2021

Press news Biocartis Group NV: Disclosure of a transparency notification Press news Biocartis Group NV: Disclosure of a transparency notification PRESS RELEASE: REGULATED INFORMATION … Continue reading →

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Regulation 40

BioTech 365

NOVEMBER 10, 2021

Press release Biocartis Group NV: Biocartis Q3 2021 Business Update Press release Biocartis Group NV: Biocartis Q3 2021 Business Update PRESS RELEASE: REGULATED INFORMATION10 November 2021, 07:00 CET BIOCARTIS Q3 2021 BUSINESS UPDATE Mechelen, Belgium, 10 November 2021 – Biocartis Group … Continue reading →

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Regulation 40

BioTech 365

AUGUST 6, 2021

AB Science publishes a Q&A press release, following-up on its June 28, 2021 press release relating to an agreement with historical shareholders AB Science publishes a Q&A press release, following-up on its June 28, 2021 press release relating to an … Continue reading →

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BioTech 365

AUGUST 29, 2021

Press release Biocartis Group NV: Disclosure of a transparency notification Press release Biocartis Group NV: Disclosure of a transparency notification PRESS RELEASE: REGULATED INFORMATION 30 August 2021, 07:00 CEST Disclosure of a transparency notification Mechelen, Belgium, (..)

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Regulation 40

BioTech 365

SEPTEMBER 1, 2021

Press release Biocartis Group NV: Biocartis announces H1 2021 results Press release Biocartis Group NV: Biocartis announces H1 2021 results PRESS RELEASE: REGULATED INFORMATION2 September 2021, 07:01 CEST BIOCARTIS ANNOUNCES H1 2021 RESULTS H1 2021 results: Very strong growth with 156k … Continue reading →

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Regulation 40

BioSpace

AUGUST 11, 2020

Although the world is eagerly awaiting news of an effective and safe vaccine against COVID-19, several companies are moving ahead testing therapeutic antibodies against the disease.

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Antibody Vaccination Vaccine 135

BioTech 365

AUGUST 26, 2021

Rebuttal to 8/25/21 Cassava Sciences Press Release Rebuttal to 8/25/21 Cassava Sciences Press Release WASHINGTON–(BUSINESS WIRE)–On August 18, 2021, Jordan Thomas of Labaton Sucharow filed a Citizen Petition to the FDA on behalf of our clients who collectively have expertise … Continue reading →

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BioTech 365

JANUARY 20, 2022

Correction: Opiant Pharmaceuticals Corrects Error in Issuing Duplicate Press Release Today Correction: Opiant Pharmaceuticals Corrects Error in Issuing Duplicate Press Release Today SANTA MONICA, Calif., 20, 2022 (GLOBE NEWSWIRE) — Correction: Opiant Pharmaceuticals, Inc.

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Pharmaceutical Technology

DECEMBER 1, 2023

Hot on the heels of the designation, Orchard Therapeutics is pressing ahead with a multi-centre trial for the candidate with a start date in December.

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Gene Therapy Gene Trials 246

BioTech 365

FEBRUARY 17, 2021

Akers Biosciences Responds to Erroneous Earnings Call Press Release Akers Biosciences Responds to Erroneous Earnings Call Press Release NEW YORK–(BUSINESS WIRE)–Akers Biosciences, Inc.

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BioTech 365

MAY 19, 2021

IBA Press Release: IBA Business Update – First Quarter 2021 IBA Press Release: IBA Business Update – First Quarter 2021 Louvain-La-Neuve, Belgium, 20 May 2021 – IBA (Ion Beam Applications S.A., EURONEXT), the world’s leading provider of proton therapy solutions … Continue reading →

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BioTech 365

APRIL 21, 2021

Press release Biocartis Group NV: BIOCARTIS Q1 2021 BUSINESS UPDATE Press release Biocartis Group NV: BIOCARTIS Q1 2021 BUSINESS UPDATE PRESS RELEASE: REGULATED INFORMATION22 April 2021, 07:01 CEST BIOCARTIS Q1 2021 BUSINESS UPDATE70% Cartridge Volume Growth in Q1 2021; New Partnership … Continue reading →

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Regulation 40

BioTech 365

MAY 16, 2021

Press release Biocartis Group NV: Invitation to the Extraordinary Shareholders’ Meeting Press release Biocartis Group NV: Invitation to the Extraordinary Shareholders’ Meeting PRESS RELEASE: REGULATED INFORMATION 17 May 2021, 07:00 CEST Invitation to the Extraordinary Shareholders’ Meeting Mechelen, Belgium, 17 May … Continue reading → (..)

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Regulation 40