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

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

RFK Jr. could 'cost lives in this country' if he pursues changes to US vaccine policy, Gottlieb says

Fierce Pharma

DECEMBER 2, 2024

Department of Health and Human Services immediately sent waves of speculation swirling throughout the biopharma industry. | The former FDA Commissioner pointed to the threat of measles if vaccination rates were to decline by 5%. Kennedy Jr.’s s appointment last month to lead the U.S.

Biopharma

Biopharma FDA Leads

After FDA setbacks, Lexicon slashes commercial operations in transition back to clinical-stage outfit

Fierce Pharma

NOVEMBER 22, 2024

For many biopharmas, it takes years of hard work to transition from being a clinical-stage drugmaker to a commercial one. The pivot comes after the FDA issued a notice that the deficiencies in the company's approval bid for type 1 diabetes med Zynquista are too great to proceed for further discussion.

FDA

FDA Biopharma

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

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

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

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

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

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

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

FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug

MedCity News

NOVEMBER 25, 2024

But new competition to both products could come soon from Alnylam Pharmaceuticals, now set to receive an FDA decision in this indication by late March. The post FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug appeared first on MedCity News.

Competition

Competition FDA Pharma Pharmaceutical

Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose

MedCity News

NOVEMBER 22, 2024

A patient death in a clinical trial usually prompts the FDA to impose a clinical hold. But Neurogene is able to avoid a lengthy clinical trial pause largely because of its participation in an FDA pilot program intended to speed up the development of therapies for rare diseases.

FDA

FDA Patients 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 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

Vertex’s CRISPR Gene Therapy Lands Another FDA Nod in a Rare Blood Disease

MedCity News

JANUARY 16, 2024

The FDA approved Vertex Pharmaceuticals’ gene therapy Casgevy for treating beta thalassemia, an inherited blood disease that leads to low levels of functioning hemoglobin. Last month, the one-time treatment won its first FDA nod for treating sickle cell disease.

FDA

FDA Pharmaceutical Leads 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 first gene therapy for Haemophilia B

European Pharmaceutical Review

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes.

FDA

FDA Food and Drug Administration Biopharma Food

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

Ipsen Joins the ADC Chase, Licensing Phase 1-Ready Asset for Novel Cancer Target

MedCity News

APRIL 2, 2024

Ipsen is acquiring global rights to a Sutro Biopharma antibody drug conjugate for a target that is not yet hit by any FDA-approved drugs. Merck is among the companies pursuing this target, but Sutro claims its ADC could be first and best in this class.

Biopharma

Biopharma FDA Pharma

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 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

‘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

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

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

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

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

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

Blockbuster BeiGene Cancer Drug Adds Another FDA Approval

MedCity News

MARCH 10, 2024

The FDA approved BeiGene’s Brukinsa as a treatment for advanced cases of follicular lymphoma. It’s the fifth FDA nod for the drug, which has become BeiGene’s top-selling product.

FDA

FDA Biopharma Pharma

A First for Fatty Liver: FDA Approves Madrigal Pharma NASH Drug

MedCity News

MARCH 14, 2024

The FDA has approved Madrigal Pharmaceuticals drug Rezdiffra as a treatment for the fatty liver disease NASH (also called MASH). It’s the first treatment for the chronic condition, which has been growing in prevalence.

FDA

FDA Pharma Pharmaceutical Biopharma

Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval

MedCity News

MAY 17, 2024

Amgen’s Imdelltra has FDA approval in extensive-stage small cell lung cancer, making it the first bispecific T cell engager approved for treating this type of cancer. The post Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval appeared first on MedCity News.

FDA

FDA Biopharma Pharma

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 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

Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

MedCity News

APRIL 15, 2024

The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. The post Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug appeared first on MedCity News.

Safety

Safety FDA Leads Biopharma

AstraZeneca’s Rare Disease Pipeline Notches Another FDA Approval

MedCity News

APRIL 1, 2024

The FDA approved AstraZeneca drug Voydeya as an add-on to standard therapies for paroxysmal nocturnal hemoglobinuria, a rare blood disorder. Alexion, now AstraZeneca’s rare disease subsidiary, added the small molecule to its pipeline via a 2019 acquisition.

FDA

FDA Biopharma Pharma

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

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

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

Applied Therapeutics Drug Is Denied FDA Approval in Rare Inherited Metabolic Disease

MedCity News

DECEMBER 2, 2024

The FDA cited deficiencies in its govorestat’s application in galactosemia, a rare metabolic disease, Applied Therapeutics said. The biotech is still on track to submit a separate application for the drug in sorbitol dehydrogenase (SORD) deficiency, another rare disease that has no FDA-approved therapies.

FDA

FDA Biopharma Pharma

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

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

FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

MedCity News

APRIL 24, 2024

Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The post FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer appeared first on MedCity News.

FDA

FDA Patients Biopharma Pharma

FDA Issues Alert to Mitigate Risks to a Widely Used Allergy, Nausea Drug

MedCity News

DECEMBER 28, 2023

The FDA said promethazine hydrochloride, a generic drug used to manage allergies and motion sickness, should be administered by intramuscular injection. Intravenous injection can cause chemical irritation and tissue damage, an FDA alert states.

FDA

FDA Management Biopharma Pharma

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

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

Trending Sources

RFK Jr. could 'cost lives in this country' if he pursues changes to US vaccine policy, Gottlieb says

After FDA setbacks, Lexicon slashes commercial operations in transition back to clinical-stage outfit

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

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

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

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

ArriVent’s lung cancer therapy gains FDA breakthrough therapy status

Biopharma sees strong Q2 2023 market cap growth

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

FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug

Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose

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

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

Enabling Clinical Trial Innovation Through AI Regulation at FDA

Vertex’s CRISPR Gene Therapy Lands Another FDA Nod in a Rare Blood Disease

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

FDA approves first gene therapy for Haemophilia B

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

Ipsen Joins the ADC Chase, Licensing Phase 1-Ready Asset for Novel Cancer Target

FDA Takes Step Toward Removal of Ineffective Decongestants From the Market

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

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

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

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

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

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

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

Blockbuster BeiGene Cancer Drug Adds Another FDA Approval

A First for Fatty Liver: FDA Approves Madrigal Pharma NASH Drug

Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval

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

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

Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

AstraZeneca’s Rare Disease Pipeline Notches Another FDA Approval

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

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

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

Applied Therapeutics Drug Is Denied FDA Approval in Rare Inherited Metabolic Disease

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

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

FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

FDA Issues Alert to Mitigate Risks to a Widely Used Allergy, Nausea Drug

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