Biopharma, Competition, FDA and 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

Ionis Rare Disease Drug Is Headed to FDA, But Forthcoming Data Will Decide Competitive Profile

MedCity News

JANUARY 22, 2024

If Ionis can commercialize this drug, competition would include products from Takeda Pharmaceutical and BioCryst Pharmaceuticals. In its Phase 3 test, Ionis Pharmaceuticals drug donidalorsen reduced the frequency of swelling attacks caused by the rare disease hereditary angioedema.

Competition

Competition Pharmaceutical FDA Biopharma

Sanofi’s FDA Nod in Hemophilia Gives Patients More Convenience, Brings Roche New Competition

MedCity News

FEBRUARY 23, 2023

FDA approval of Sanofi hemophilia A drug Altuviiio provides patients with a therapeutic option that lasts longer than most other products available, including one already marketed by the French pharma giant. Altuviiio also gives Sanofi a way to better compete against blockbuster Roche drug Hemlibra.

Competition

Competition FDA Patients Pharma

FDA Approves Roche Lymphoma Drug, Bringing Competition to New AbbVie Med

MedCity News

JUNE 16, 2023

The FDA approved Roche’s Columvi as a third-line treatment for a type of blood cancer called diffuse large B-cell lymphoma. This new Roche drug will compete against Epkinly, AbbVie’s recently approved DLBCL drug.

Competition

Competition FDA Biopharma Pharma

FDA Approval of Mirati Lung Cancer Drug Sets Stage for Competition With Amgen

MedCity News

DECEMBER 13, 2022

Amgen’s Lumakras became the first FDA-approved drug that addresses the elusive KRAS mutation, but Mirati believes its newly approved therapy, Krazati, could be better. The small molecule’s features include the ability to penetrate into the brain, where it can address cancer that has spread to the central nervous system.

Competition

Competition FDA Biopharma Pharma

FDA Approval of Pfizer Alopecia Drug Brings New Competition to Eli Lilly Med

MedCity News

JUNE 26, 2023

Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.

Competition

Competition FDA Biopharma Pharma

Pharma M&A rumour mill grinds out Mirati’s name again

pharmaphorum

NOVEMBER 24, 2022

Mirati Therapeutics is the subject of takeover speculation in the biopharma sector once again, as it waits for the FDA’s decision on its KRAS inhibitor adagrasib in non-small cell lung cancer (NSCLC). The post Pharma M&A rumour mill grinds out Mirati’s name again appeared first on.

Pharma

Pharma Biopharma FDA Competition

Rare Disease Drug Approval Brings New Competition to Meds from Sanofi, Takeda

MedCity News

MAY 10, 2023

A drug developed by Protalix BioTherapeutics and Chiesi Group is now FDA approved for treating Fabry disease, a rare inherited metabolic disorder. The drug, Elfabrio, is an enzyme replacement therapy.

Competition

Competition FDA Biopharma Pharma

TheracosBio Drug Approval Puts It in Competition With Blockbuster Diabetes Meds

MedCity News

JANUARY 23, 2023

The FDA approved TheracosBio’s Brenzavvy as a treatment for type 2 diabetes. But before it won a regulatory nod for controlling blood glucose in adults, it was approved at a different dose (with flavor) as a veterinary product.

Competition

Competition FDA Biopharma Pharma

Downturn for top biopharma companies Q3 market cap as Covid-19 vaccine demand falls

Pharmaceutical Technology

DECEMBER 20, 2022

trillion in Q3, according to GlobalData’s Pharma Intelligence Center Companies Database. The growing competition from generic drugs presents challenges for the top 20 players placing pressure on drug prices. The top 20 global biopharmaceutical companies exhibited a downward trend in aggregate market capitalisation by 9.1%

Biopharma

Biopharma Marketing Competition Sales

How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

pharmaphorum

DECEMBER 28, 2022

M&A is an integral part of the lifecycle of pharma companies and a key strategy to future-proof larger players, driving R&D activities and innovation for a competitive product pipeline. Since the first wave of consolidation started in 1988, there has been a significant concentration of the pharma industry.

Pharma

Pharma Pharmaceutical manufacturing Pharmaceutical Manufacturing

Alnylam drug succeeds in heart study, setting stage for FDA filing and showdown with Pfizer

MedCity News

AUGUST 3, 2022

Alnylam Pharmaceuticals drug Onpattro, an FDA-approved treatment for nerve pain caused by hereditary transthyretin amyloidosis, now has Phase 3 data showing it can also help the much larger group of patients suffering heart problems from the rare protein disease.

FDA

FDA Competition Pharmaceutical Patients

Market cap growth surges for over half of the top biopharmaceutical companies in 2022

Pharmaceutical Technology

FEBRUARY 8, 2023

The top 20 companies in the global biopharma industry saw 5.4%* aggregate market capitalization from $3.43 trillion over the past year, according to GlobalData’s Pharma Intelligence Center Companies Database. billion for 2022, according to GlobalData’s Drugs Database Pharma Intelligence Center. trillion to $3.61 to $365.84.

Marketing

Marketing Biopharma Sales Pharma

Pharma R&D productivity dips, but efficiency gains give hope

Clarivate

JANUARY 23, 2024

While some industry observers read this drop as a clear decline in productivity, others take a more optimistic view, attributing the decline to FDA submission calendar fluctuations and noting that 2022 numbers were not very different from the ten-year average. In fact, the number of NMEs has grown by 65% between 2013 and 2022.

Pharma

Pharma Sales Consulting Pharmaceutical

The AMJEVITA impact: Innovative U.S. biosimilar pricing models

Clarivate

JULY 5, 2023

The month of July could see seven FDA-approved adalimumab biosimilars launch in the United States, an unprecedented situation for a market that has been relatively slow to embrace biosimilars. The Biosimilars Forum has hailed 2022 as a watershed year that could create a more competitive U.S. from 91% in 2023 to 36% by 2031.

Marketing

Marketing Physicians Manufacturing Competition

ESMO 2022: Ten key takeaways on Europe’s top oncology event

Clarivate

OCTOBER 10, 2022

Based on the TROPICS-02 trial results, Gilead has submitted a supplemental biologics license application (sBLA) to the FDA, seeking a label expansion for TRODELVY in the much larger setting of metastatic HR+/HER2-negative breast cancer. Fruquintinib will face fierce competition should it be approved in the third- and later-line setting.

Marketing

Marketing Safety Patients Competition

Gene therapies transform rare disease treatment: hope for patients amidst regulatory, payer and developer challenges

Clarivate

MAY 24, 2023

A narrow FDA AdComm vote in favor of accelerated approval for Sarepta’s first-in-class gene transfer therapy illustrates challenges faced by regulators, payers and developers as a wave of innovative genetic treatments for rare diseases comes to market.

Patients

Patients Food and Drug Administration Biopharma FDA

CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

Pharmaceutical Technology

MARCH 21, 2023

In this month’s edition, which covers events from late January to early March, manufacturing contract-related data from GlobalData’s PharmSource reports and news from GlobalData’s Pharma Intelligence Center have been collated to identify stakeholders at the center of new developments.

Manufacturing

Manufacturing Pharmaceutical Biopharma FDA

CMO Moves: Regulatory catalysts for therapy manufacturing -January

Pharmaceutical Technology

JANUARY 15, 2023

In order to get a therapy to the market, pharma companies often outsource the drug manufacturing to specialist contract manufacturing organizations (CMOs). While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. FDA expands approval labels.

Manufacturing

Manufacturing Pharmaceutical FDA Pharma

FDA approves Biostar’s Phase II/III plans with utidelone injectable for NSCLC

Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study.

FDA

FDA Food and Drug Administration Patients Marketing

CMO Moves: Regulatory catalysts for drug manufacturing- February

Pharmaceutical Technology

FEBRUARY 27, 2023

To identify key events from late December to late January, this news service collated manufacturing contract-related data from PharmSource reports, and news from GlobalData’s Pharma Intelligence Center, to identify participants that are likely to experience an impact following the news.

Manufacturing

Manufacturing Pharmaceutical Pharma FDA

Pharma Rep Focus

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

Ionis Rare Disease Drug Is Headed to FDA, But Forthcoming Data Will Decide Competitive Profile

Trending Sources

Sanofi’s FDA Nod in Hemophilia Gives Patients More Convenience, Brings Roche New Competition

FDA Approves Roche Lymphoma Drug, Bringing Competition to New AbbVie Med

FDA Approval of Mirati Lung Cancer Drug Sets Stage for Competition With Amgen

FDA Approval of Pfizer Alopecia Drug Brings New Competition to Eli Lilly Med

Pharma M&A rumour mill grinds out Mirati’s name again

Rare Disease Drug Approval Brings New Competition to Meds from Sanofi, Takeda

TheracosBio Drug Approval Puts It in Competition With Blockbuster Diabetes Meds

Downturn for top biopharma companies Q3 market cap as Covid-19 vaccine demand falls

How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

Alnylam drug succeeds in heart study, setting stage for FDA filing and showdown with Pfizer

Market cap growth surges for over half of the top biopharmaceutical companies in 2022

Pharma R&D productivity dips, but efficiency gains give hope

The AMJEVITA impact: Innovative U.S. biosimilar pricing models

ESMO 2022: Ten key takeaways on Europe’s top oncology event

Gene therapies transform rare disease treatment: hope for patients amidst regulatory, payer and developer challenges

CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

CMO Moves: Regulatory catalysts for therapy manufacturing -January

FDA approves Biostar’s Phase II/III plans with utidelone injectable for NSCLC

CMO Moves: Regulatory catalysts for drug manufacturing- February

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