Biopharma and FDA - Pharma Rep Focus

FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard

Fierce Pharma

MARCH 11, 2024

The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.

FDA

FDA Biopharma

Despite fears over RFK Jr. pick, industry should focus more on FDA job: analyst

Fierce Pharma

NOVEMBER 18, 2024

may not rock the boat as much as feared for the biopharma industry. Robert F. | In a contrarian take offered by BMO Capital Markets' Evan Seigerman, the analyst said Robert F. Kennedy Jr.

Biopharma

Biopharma FDA Marketing

Amgen's request for full approval of Lumakras in lung cancer denied by FDA

Fierce Pharma

DECEMBER 27, 2023

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California biopharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod.

FDA

FDA Biopharma

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Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

Fierce Pharma

AUGUST 20, 2024

As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem. |

Biopharma

Biopharma FDA

Biopharma Recap: Q3 2024

Zymewire

OCTOBER 15, 2024

In our Q3 2024 biopharma recap, we dive into the latest trends in funding, clinical trial activity, and therapeutic focus areas across the industry. With updated data on regional funding shifts and insights into the evolving biopharma landscape, this report will help CROs and CDMOs refine their strategies as they prepare for 2025.

Biopharma

Biopharma FDA

SCOTUS overturn of Chevron doctrine opens a Pandora's box for biopharma industry, expert says

Fierce Pharma

AUGUST 27, 2024

In June, when the Supreme Court voted 6-3 to overturn the Chevron doctrine, it brought significant impact for the healthcare industry and federal regulators like the FDA and the Centers for Medicare & Medicaid Services. An expert recently discussed the ramifications of the ruling during a Fierce Pharma podcast interview.

Biopharma

Biopharma FDA Pharma Healthcare

Biopharma sees strong Q2 2023 market cap growth

European Pharmaceutical Review

AUGUST 21, 2023

Q2 2023 biopharma market capitalisation results Eli Lilly “Eli Lilly witnessed the largest market capitalisation growth of 36.1 Lilly completes biopharma acquisitions GlobalData highlighted that Eli Lilly reported its synthetic peptide Mounjaro had $980 million in global sales in Q2. trillion in the Q1 of 2023 to $3.56

Biopharma

Biopharma Marketing Sales Medicine

‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

MedCity News

NOVEMBER 10, 2024

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. The post ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer appeared first on MedCity News.

FDA

FDA Engineering Safety Biopharma

ArriVent’s lung cancer therapy gains FDA breakthrough therapy status

Pharmaceutical Technology

OCTOBER 31, 2023

ArriVent Biopharma has received the US FDA's breakthrough therapy designation for furmonertinib to treat non-small cell lung cancer.

FDA

FDA Biopharma

FDA Takes Step Toward Removal of Ineffective Decongestants From the Market

MedCity News

NOVEMBER 8, 2024

The FDA has proposed removing oral phenylephrine from its guidelines for over-the-counter drugs due to inefficacy as a decongestant. The post FDA Takes Step Toward Removal of Ineffective Decongestants From the Market appeared first on MedCity News.

FDA

FDA Marketing Medicine Biopharma

FDA approves Accord BioPharma’s HERCESSI for cancer treatment

Pharmaceutical Technology

SEPTEMBER 19, 2024

Accord BioPharma received FDA approval for 420mg HERCESSI, a biosimilar to Herceptin to treat various kinds of HER2-overexpressing cancers.

FDA

FDA Biopharma

Pfizer acquires biopharma firm Biohaven for $11.6bn

Pharmaceutical Technology

OCTOBER 4, 2022

A CGRP receptor antagonist, NURTEC ODT is approved by the US Food and Drug Administration (FDA) for use in adults for acute treatment of migraine irrespective of aura status as well as for preventive episodic migraine treatment. The post Pfizer acquires biopharma firm Biohaven for $11.6bn appeared first on Pharmaceutical Technology.

Biopharma

Biopharma Food and Drug Administration Medicine FDA

Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M

MedCity News

NOVEMBER 6, 2024

The biotech received the voucher last year alongside the regulatory decision that made its drug Daybue the first FDA-approved treatment for the rare disease Rett syndrome. The post Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M appeared first on MedCity News.

FDA

FDA Pharma Pharmaceutical Biopharma

Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer

MedCity News

OCTOBER 16, 2024

The FDA approved Novocure medical device Optune Luna as a treatment for advanced cases of non-small cell lung cancer. The post Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer appeared first on MedCity News. The wearable technology delivers electrical fields that kill cancer cells.

Medical

Medical FDA Biopharma Pharma

FDA Approves New Dose Strength of Herceptin Biosimilar for HER2-Overexpressing Breast, Gastric Cancers

Pharmaceutical Commerce

SEPTEMBER 18, 2024

Accord BioPharma's 420 mg strength Hercessi (trastuzumab-strf), a biosimilar to Herceptin, gains FDA approval to treat HER2-overexpressing breast cancer and gastric cancer.

FDA

FDA Biopharma

FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff

MedCity News

JUNE 21, 2024

FDA reviewers concluded the data for Sarepta Therapeutics’ Elevidys were insufficient to show efficacy in the rare muscle disorder Duchenne muscular dystrophy. The post FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff appeared first on MedCity News.

FDA

FDA Biopharma Pharma

PTC Therapeutics Wins First FDA Approval for a Gene Therapy Dosed Directly Into the Brain

MedCity News

NOVEMBER 14, 2024

FDA approval for the product comes two years after it won its first regulatory approvals in Europe. The post PTC Therapeutics Wins First FDA Approval for a Gene Therapy Dosed Directly Into the Brain appeared first on MedCity News.

FDA

FDA Biopharma Pharma

Accord BioPharma’s HERCESSI secures FDA approval

Pharmaceutical Technology

APRIL 30, 2024

Accord BioPharma, the division of Intas Pharmaceuticals, has secured approval from the US FDA for HERCESSI, a biosimilar to Herceptin.

FDA

FDA Biopharma Pharmaceutical

Q1 Biopharma Recap

Zymewire

APRIL 22, 2024

Summary of funding events, FDA approvals, clinical trial stats, and upcoming research and development plans from the world of biotech and pharma in Q1 2024

Biopharma

Biopharma FDA Pharma

Top biopharma firms report Q3 market capitalisation decline

European Pharmaceutical Review

DECEMBER 6, 2022

Sharon Cartic, Associate Director for Business Fundamentals Databases at GlobalData commented: “Daiichi Sankyo experienced boosted sales with its partner AstraZeneca for cancer drug Enhertu after receiving US Food and Drug Administration (FDA) approval in Q3 for HER2-low metastatic breast cancer and HER2-mutant metastatic non-small lung cancer.”.

Biopharma

Biopharma Marketing Food and Drug Administration Sales

FDA Authorizes First At-Home, OTC Diagnostic Test for Syphilis

MedCity News

AUGUST 18, 2024

NOWDiagnostics’ First to Know has FDA De Novo marketing authorization as a new test for syphilis. The post FDA Authorizes First At-Home, OTC Diagnostic Test for Syphilis appeared first on MedCity News. The at-home product needs only a single drop of blood to test for this sexually transmitted infection.

FDA

FDA Marketing Biopharma

Enabling Clinical Trial Innovation Through AI Regulation at FDA

MedCity News

JULY 29, 2024

As the FDA stakes its claim as the primary regulator of AI in healthcare, it must navigate the delicate balance between fostering innovation and ensuring safety and responsibility. The post Enabling Clinical Trial Innovation Through AI Regulation at FDA appeared first on MedCity News.

FDA

FDA Safety Healthcare Healthcare

Amgen to acquire biopharma firm ChemoCentryx for $3.7bn

Pharmaceutical Technology

AUGUST 5, 2022

An orally administered selective inhibitor of complement component 5a receptor, Tavneos received approval from the US Food and Drug Administration (FDA) in October last year. The post Amgen to acquire biopharma firm ChemoCentryx for $3.7bn appeared first on Pharmaceutical Technology.

Biopharma

Biopharma Food and Drug Administration Food Marketing

Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval

MedCity News

NOVEMBER 18, 2024

The post Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval appeared first on MedCity News. Other companies developing menin inhibitors include Kura Oncology, Biomea Fusion, and Johnson & Johnson subsidiary Janssen.

Pharmaceutical

Pharmaceutical FDA Biopharma Pharma

FTC Sees Red Over Alleged Misuse of FDA Orange Book, Puts 10 Pharmas on Notice

MedCity News

NOVEMBER 7, 2023

The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.

Biopharma

Biopharma Competition FDA Pharma

FDA Approval Makes a Zevra Drug the First Therapy for Rare and Fatal Metabolic Disease

MedCity News

SEPTEMBER 20, 2024

Zevra Therapeutics drug Miplyffa is now FDA approved for Niemann-Pick disease type C, a lysosomal storage disorder. The affirmative regulatory decision took into account additional clinical data generated since the FDA turned down a submission for the drug in 2021.

FDA

FDA Biopharma Pharma

Sanofi and Regeneron Biologic Drug Dupixent Notches a New FDA Approval in COPD

MedCity News

SEPTEMBER 29, 2024

It’s the sixth FDA-approved indication for the blockbuster drug. The post Sanofi and Regeneron Biologic Drug Dupixent Notches a New FDA Approval in COPD appeared first on MedCity News.

FDA

FDA Pharmaceutical Biopharma Pharma

Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas

MedCity News

SEPTEMBER 6, 2024

The FDA decision for Travere Therapeutics’ Filspari also expands its addressable patient population. The post Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas appeared first on MedCity News.

Competition

Competition FDA Patients Biopharma

Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency

MedCity News

AUGUST 12, 2024

FDA approval of Ascendis Pharma’s Yorvipath is just in time for patients with hypoparathyroidism as Takeda Pharmaceutical will soon stop making the only drug therapy for the rare disorder. The post Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency appeared first on MedCity News.

FDA

FDA Pharma Competition Pharmaceutical

With New Huntington’s Gene Therapy Data, uniQure Hopes for Faster Path With FDA

MedCity News

JULY 9, 2024

An accelerated approval pathway is one of the topics the company wants to discuss with the FDA. The post With New Huntington’s Gene Therapy Data, uniQure Hopes for Faster Path With FDA appeared first on MedCity News.

FDA

FDA Biopharma Pharma

Ipsen beefs up in oncology, buying US biopharma Epizyme

pharmaphorum

JUNE 27, 2022

Tazverik is a first-in-class EZH2a inhibitor that was cleared by the FDA in 2020 as a third-line or later treatment for adults with relapsed or refractory follicular lymphoma (FL) whose tumours have an EZH2 mutation. The post Ipsen beefs up in oncology, buying US biopharma Epizyme appeared first on.

Biopharma

Biopharma Sales Prescription FDA

FDA Awards Accelerated Approval to Gilead Sciences Drug for Rare Liver Disease

MedCity News

AUGUST 14, 2024

Livdelzi is now FDA-approved for treating the rare liver disease primary biliary cholangitis. The post FDA Awards Accelerated Approval to Gilead Sciences Drug for Rare Liver Disease appeared first on MedCity News. Gilead Sciences added the drug to its pipeline via the $4.3 billion acquisition of CymaBay Therapeutics earlier this year.

FDA

FDA Biopharma Pharma

Pharma Pulse 9/5/24: FDA Wants Safer Cancer Drugs, Can Outcomes-Based Agreements Work for Weight Loss Drugs? & more

Pharmaceutical Commerce

SEPTEMBER 5, 2024

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

Distribution

Distribution Biopharma Pharma Marketing

Highly Anticipated FDA Decision Comes Just in Time for Back-to-School Season

MedCity News

SEPTEMBER 2, 2024

FDA approval of neffy, a nasal spray formulation of epinephrine, clears the way for ARS Pharma to launch the product in time for the new school year. In other recent regulatory news, the FDA approved updated Covid-19 vaccines as well as a new mpox vaccine.

FDA

FDA Pharma Biopharma

Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi

MedCity News

JULY 2, 2024

Eli Lilly’s Kisunla is now FDA approved for treating patients in the early stages of Alzheimer’s disease. The post Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi appeared first on MedCity News.

Competition

Competition FDA Patients Biopharma

FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma

MedCity News

AUGUST 21, 2024

Regeneron Pharmaceuticals said the FDA cited no approvability concerns for its multiple myeloma drug, linvoseltamab, other than previously identified issues with a contract manufacturer. The post FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma appeared first on MedCity News.

FDA

FDA Manufacturing Pharmaceutical Marketing

Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Rare Brain Cancer

MedCity News

AUGUST 6, 2024

The FDA approved Servier Pharmaceuticals’ Voranigo as a treatment for two types of low-grade gliomas. The post Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Rare Brain Cancer appeared first on MedCity News. The drug, which is projected to become a blockbuster product, comes from Servier’s $1.8

FDA

FDA Pharmaceutical Biopharma Pharma

FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

MedCity News

APRIL 23, 2024

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The post FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery appeared first on MedCity News. The novel immunotherapy works by sparking activity from three types of immune cells.

FDA

FDA Patients Biopharma Pharma

A sad day for us all as the FDA continues to lose credibility

World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers. Where to start? John Carroll, Endpoints.

FDA

FDA Food and Drug Administration Patients Biopharma

FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin

MedCity News

JULY 12, 2024

The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news.

FDA

FDA Manufacturing Patients Biopharma

FDA Approves Moderna RSV Vaccine, an mRNA Alternative to GSK and Pfizer Products

MedCity News

MAY 31, 2024

Moderna’s mResvia is now the third FDA-approved RSV vaccine and the first one based on mRNA technology. It will compete for market share against RSV shots from GSK and Pfizer that won their FDA nods last year. The post FDA Approves Moderna RSV Vaccine, an mRNA Alternative to GSK and Pfizer Products appeared first on MedCity News.

FDA

FDA Marketing Biopharma Pharma

FDA Approves Argenx Drug as First New Treatment in Decades for Rare Nerve Disease CIDP

MedCity News

JUNE 24, 2024

The drug, an FcRn inhibitor, is the first in its class to win FDA approval in CIDP. The post FDA Approves Argenx Drug as First New Treatment in Decades for Rare Nerve Disease CIDP appeared first on MedCity News.

FDA

FDA Biopharma Pharma

FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

MedCity News

APRIL 1, 2024

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. The post FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

FDA

FDA Medical Pharmaceutical Biopharma

FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades

MedCity News

SEPTEMBER 27, 2024

The post FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades appeared first on MedCity News. Bristol Myers Squibb’s Cobenfy treats schizophrenia by going after a different target than currently available antipsychotic drugs, which is intended to offer better efficacy and safety.

FDA

FDA Safety Pharma Biopharma

FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard

Despite fears over RFK Jr. pick, industry should focus more on FDA job: analyst

Webinars

Trending Sources

Amgen's request for full approval of Lumakras in lung cancer denied by FDA

Webinars

Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

Biopharma Recap: Q3 2024

SCOTUS overturn of Chevron doctrine opens a Pandora's box for biopharma industry, expert says

Biopharma sees strong Q2 2023 market cap growth

‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

ArriVent’s lung cancer therapy gains FDA breakthrough therapy status

FDA Takes Step Toward Removal of Ineffective Decongestants From the Market

FDA approves Accord BioPharma’s HERCESSI for cancer treatment

Pfizer acquires biopharma firm Biohaven for $11.6bn

Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M

Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer

FDA Approves New Dose Strength of Herceptin Biosimilar for HER2-Overexpressing Breast, Gastric Cancers

FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff

PTC Therapeutics Wins First FDA Approval for a Gene Therapy Dosed Directly Into the Brain

Accord BioPharma’s HERCESSI secures FDA approval

Q1 Biopharma Recap

Top biopharma firms report Q3 market capitalisation decline

FDA Authorizes First At-Home, OTC Diagnostic Test for Syphilis

Enabling Clinical Trial Innovation Through AI Regulation at FDA

Amgen to acquire biopharma firm ChemoCentryx for $3.7bn

Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval

FTC Sees Red Over Alleged Misuse of FDA Orange Book, Puts 10 Pharmas on Notice

FDA Approval Makes a Zevra Drug the First Therapy for Rare and Fatal Metabolic Disease

Sanofi and Regeneron Biologic Drug Dupixent Notches a New FDA Approval in COPD

Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas

Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency

With New Huntington’s Gene Therapy Data, uniQure Hopes for Faster Path With FDA

Ipsen beefs up in oncology, buying US biopharma Epizyme

FDA Awards Accelerated Approval to Gilead Sciences Drug for Rare Liver Disease

Pharma Pulse 9/5/24: FDA Wants Safer Cancer Drugs, Can Outcomes-Based Agreements Work for Weight Loss Drugs? & more

Highly Anticipated FDA Decision Comes Just in Time for Back-to-School Season

Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi

FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma

Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Rare Brain Cancer

FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

A sad day for us all as the FDA continues to lose credibility

FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin

FDA Approves Moderna RSV Vaccine, an mRNA Alternative to GSK and Pfizer Products

FDA Approves Argenx Drug as First New Treatment in Decades for Rare Nerve Disease CIDP

FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades

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