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

After swell of biopharma outrage, Supreme Court takes up high-profile mifepristone case

Fierce Pharma

DECEMBER 13, 2023

That's because the original verdict questioned the FDA's decision-making authority, prompting amicus brief submissions from high-profile industry players. Wade, abortion access is back up for debate in the Supreme Court. | The Supreme Court's final decision could have consequences beyond abortion access.

Biopharma

Biopharma FDA

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

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

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

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

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

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 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

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

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

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

Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

MedCity News

APRIL 8, 2024

The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products. The post Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs appeared first on MedCity News.

FDA

FDA Patients Marketing Biopharma

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

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

Akebia Recovers From Rejection to Win FDA Approval for Anemia Drug

MedCity News

MARCH 31, 2024

The FDA rejected the drug two years ago due to concerns about cardiovascular safety. Approval of Akebia Therapeutics’ Vafseo is based on additional post-marketing safety data from Japan, where the drug has been used since 2020.

FDA

FDA Safety Marketing Biopharma

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

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

Gene Therapy Is Now First FDA-Approved Treatment for Rare & Fatal CNS Disorder

MedCity News

MARCH 18, 2024

Orchard Therapeutics gene therapy Lenmeldy won FDA approval for treating the rare enzyme deficiency metachromatic leukodystrophy. In January, Kyowa Kirin completed its acquisition of Orchard, which now operates as a subsidiary of the Japanese drugmaker.

FDA

FDA Biopharma Pharma

FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

MedCity News

MARCH 22, 2024

FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease. Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects.

Side effects

Side effects FDA Patients Biopharma

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

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 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 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. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers.

FDA

FDA Medical Pharmaceutical Biopharma

FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder

MedCity News

FEBRUARY 12, 2024

FDA approval of Takeda Pharmaceutical drug Eohilia introduces a new therapeutic option for patients with eosinophilic esophagitis, inflammation of the esophagus that causes swallowing difficulty. It will compete against Dupixent, a Sanofi and Regeneron Pharmaceuticals drug already approved for this disorder.

FDA

FDA Leads Pharmaceutical Patients

Regulatory twists and turns are coming for biopharma in 2024

PharmaVoice

JANUARY 8, 2024

New FDA requirements and the IRA will create complexity in the coming year. Here’s how the industry can navigate the changes.

Biopharma

Biopharma FDA

FDA Approves New First-Line Med for Pancreatic Cancer as Drug’s Initial Developer Dissolves

MedCity News

FEBRUARY 14, 2024

Ipsen’s Onivyde is now FDA approved as a first-line treatment for metastatic pancreatic cancer, triggering a milestone payment to Merrimack Pharmaceuticals, the drug’s original developer. Merrimack plans to dissolve operations but its shareholders will receive payouts from the Ipsen payment.

FDA

FDA Pharmaceutical Biopharma Pharma

FDA Approves Iovance Cancer Treatment, the First Cell Therapy for a Solid Tumor

MedCity News

FEBRUARY 19, 2024

Iovance Biotherapeutics’s Amtagvi is now the first FDA-approved treatment based on type of cell called a tumor-infiltrating lymphocyte. The regulatory nod in advanced melanoma also makes Amtagvi the first cell therapy approved for treating a solid tumor.

FDA

FDA Biopharma Pharma

FDA Probes New Cases of Cancer That May Stem From Cancer Cell Therapies

MedCity News

NOVEMBER 28, 2023

CAR T-therapies for cancer are now under tighter FDA scrutiny as the agency opens an inquiry regarding reports that some patients who received these cell therapies went on to develop new cases of cancer. The FDA said benefits of these therapies still outweigh their risks, but it is evaluating the need for regulatory action.

FDA

FDA Patients Biopharma Pharma

FDA Approves Updated Covid-19 Vaccines to Address Now Circulating Variants

MedCity News

SEPTEMBER 11, 2023

The FDA said the updated messenger RNA vaccines from Pfizer/BioNTech and Moderna will protect against the omicron subvariants now prevalent in circulation. Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review.

FDA

FDA Biopharma Pharma

Patient Death Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma

MedCity News

FEBRUARY 20, 2024

The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.

FDA

FDA Patients Safety Biopharma

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

Chiesi Rare Skin Disease Drug Acquired in Billion Dollar Deal Wins FDA Approval

MedCity News

DECEMBER 19, 2023

Chiesi Group’s Filsuvez is the second drug to win FDA approval for epidermolysis bullosa and the first for junctional EB, a more severe form of the rare skin disease. The birch tree bark-derived drug is from Chiesi’s $1.25 billion Amryt Pharma acquisition.

FDA

FDA Pharma Biopharma

Gilead’s $4.3B CymaBay Acquisition Adds Liver Disease Drug Under FDA Review

MedCity News

FEBRUARY 12, 2024

CymaBay’s molecule, seladelpar, is under FDA review for treating primary biliary cholangitis, a rare disease affecting the bile ducts of the liver. Acquiring CymaBay Therapeutics gives Gilead Sciences another drug for its liver disease portfolio.

FDA

FDA Biopharma Pharma

FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech

MedCity News

OCTOBER 15, 2023

The FDA’s digital health advisory committee will discuss technologies such as artificial intelligence and machine learning, virtual reality, and digital therapeutics as well as topics like decentralized clinical trials and patient-generated health data. Committee member nominations are due in December.

FDA

FDA Patients Biopharma

FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine

MedCity News

SEPTEMBER 20, 2023

Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission. ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen.

FDA

FDA Pharma Pharmaceutical Biopharma

Brainstorm’s ALS Data Fail to Persuade FDA Advisors, Who Vote Down the Stem Cell Therapy

MedCity News

SEPTEMBER 27, 2023

NurOwn, Brainstorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.

FDA

FDA Biopharma Pharma

Novartis Nabs FDA Nod for Rare Disease Drug Rival to AstraZeneca Meds

MedCity News

DECEMBER 6, 2023

FDA approval of Novartis’s Fabhalta makes the drug the first approved oral therapy for rare blood disorder paroxysmal nocturnal hemoglobinuria. With clinical data showing superiority versus two infused AstraZeneca drugs, Novartis’s pill is well-positioned to take market share from those blockbuster products.

FDA

FDA Marketing Biopharma Pharma

In Same Day, UCB Lands Two FDA Drug Approvals in Autoimmune Diseases

MedCity News

OCTOBER 18, 2023

FDA approval of UCB’s Bimzelx gives the Belgian drugmaker a contender in the crowded plaque psoriasis therapies market. In the rare disease generalized myasthenia gravis, the agency approved Zilbrysq, a UCB drug with advantages over two blockbuster AstraZeneca drugs addressing the same target.

FDA

FDA Marketing Biopharma Pharma

Pfizer Expands in Immunology With FDA Approval of New Ulcerative Colitis Drug

MedCity News

OCTOBER 13, 2023

Pfizer’s new FDA-approved ulcerative colitis drug Velsipity comes from its $6.7 billion Arena Pharmaceuticals acquisition. The small molecule will compete against blockbuster Bristol Myers Squibb drug Zeposia, which addresses the same target.

FDA

FDA Pharmaceutical Biopharma Pharma

FDA Approves Eli Lilly Weight Drug, Now Set to Compete Against Novo’s Wegovy

MedCity News

NOVEMBER 8, 2023

Eli Lilly weight management drug Zepbound landed its much anticipated FDA approval. The new Lilly product is in the same drug class as Novo Nordisk weight medication Wegovy, but it offers an additional mechanism of action and costs less.

FDA

FDA Management Medical Biopharma

Takeda Drug Wins First FDA Approval in Rare, Inherited Blood Clotting Disorder

MedCity News

NOVEMBER 12, 2023

Takeda Pharmaceutical enzyme replacement drug Adzynma is the first FDA-approved therapy for a rare blood disorder affecting fewer than 1,000 Americans. Our regulatory recap also includes the much-anticipated approval of an Eli Lilly weight loss drug and a crackdown on what the FTC says are improperly listed pharma product patents.

FDA

FDA Pharma Pharmaceutical Biopharma

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

After swell of biopharma outrage, Supreme Court takes up high-profile mifepristone case

Q1 Biopharma Recap

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

ArriVent’s lung cancer therapy gains FDA breakthrough therapy status

Biopharma sees strong Q2 2023 market cap growth

Pfizer acquires biopharma firm Biohaven for $11.6bn

Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

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

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

AstraZeneca’s Rare Disease Pipeline Notches Another FDA Approval

Blockbuster BeiGene Cancer Drug Adds Another FDA Approval

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

Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

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

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

Akebia Recovers From Rejection to Win FDA Approval for Anemia Drug

Amgen to acquire biopharma firm ChemoCentryx for $3.7bn

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

Gene Therapy Is Now First FDA-Approved Treatment for Rare & Fatal CNS Disorder

FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

Top biopharma firms report Q3 market capitalisation decline

Ipsen beefs up in oncology, buying US biopharma Epizyme

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

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

FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder

Regulatory twists and turns are coming for biopharma in 2024

FDA Approves New First-Line Med for Pancreatic Cancer as Drug’s Initial Developer Dissolves

FDA Approves Iovance Cancer Treatment, the First Cell Therapy for a Solid Tumor

FDA Probes New Cases of Cancer That May Stem From Cancer Cell Therapies

FDA Approves Updated Covid-19 Vaccines to Address Now Circulating Variants

Patient Death Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma

FDA approves first gene therapy for Haemophilia B

Chiesi Rare Skin Disease Drug Acquired in Billion Dollar Deal Wins FDA Approval

Gilead’s $4.3B CymaBay Acquisition Adds Liver Disease Drug Under FDA Review

FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech

FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine

Brainstorm’s ALS Data Fail to Persuade FDA Advisors, Who Vote Down the Stem Cell Therapy

Novartis Nabs FDA Nod for Rare Disease Drug Rival to AstraZeneca Meds

In Same Day, UCB Lands Two FDA Drug Approvals in Autoimmune Diseases

Pfizer Expands in Immunology With FDA Approval of New Ulcerative Colitis Drug

FDA Approves Eli Lilly Weight Drug, Now Set to Compete Against Novo’s Wegovy

Takeda Drug Wins First FDA Approval in Rare, Inherited Blood Clotting Disorder

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