FDA generic drug approvals rose in 2023 in bid for improved access
Pharmaceutical Technology
FEBRUARY 23, 2024
The FDA Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.
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Pharmaceutical Technology
FEBRUARY 23, 2024
The FDA Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.
Drug Patent Watch
JULY 25, 2024
The generic drug market has been significantly impacted by the COVID-19 pandemic, with both challenges and opportunities arising from the crisis. As the world continues to recover…
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Pharmaceutical Technology
OCTOBER 25, 2023
Experts discuss the key trends in quality improvements and API reshoring for the generic drugs market at CpHI Europe.
Drug Patent Watch
JULY 25, 2024
Developing a competitive edge in generic drug development is crucial for companies to gain a significant market share and dominate the market. Here are some key strategies and insights from industry…
Drug Patent Watch
JUNE 19, 2024
In the ever-evolving pharmaceutical landscape, savvy businesses are constantly on the lookout for untapped markets and lucrative opportunities. One area that has garnered significant attention is the realm of low-competition generic drugs.
Drug Patent Watch
OCTOBER 2, 2023
The FDA conducted a study to identify factors that may predict the likelihood of generic drug marketing applications.
Drug Patent Watch
OCTOBER 6, 2020
Here is a copy of the talk I gave at the recent Marcusevans 13th Portfolio Management and Pipeline Optimization for Generics. I cover: How to find and evaluate generic entry…. The post Finding and Evaluating Generic Drug Market Entry Opportunities appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 31, 2024
By implementing these strategies, you can can enhance your competitiveness in the market while contributing to increased access to affordable […] Source
STAT News
MARCH 30, 2023
Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs. For instance, a generic drug could be marketed to treat one type of heart problem, but not another.
BioSpace
JANUARY 14, 2021
Billionaire entrepreneur Mark Cuban, best known as the owner of the Dallas Mavericks and an investor on the ABC business reality series “Shark Tank,” is diving into generic drugs with a new startup, dubbed Mark Cuban Cost Plus Drug Company.
Drug Patent Watch
AUGUST 12, 2020
Just because a drug has received FDA approval does not mean that it is available in the marketplace. The post Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market appeared first on DrugPatentWatch - Make Better Decisions.
BioTech 365
JUNE 25, 2021
GCC Generic Drug Market Trends, Share, Size, Opportunity and Forecasts 2021-2026 – ResearchAndMarkets.com GCC Generic Drug Market Trends, Share, Size, Opportunity and Forecasts 2021-2026 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “GCC Generic Drug Market: Industry Trends, Share, Size, Growth, Opportunity and Forecast (..)
BioTech 365
OCTOBER 4, 2021
Canada Generic Drug Market Industry Trends, Share, Size, Growth, Opportunity and Forecasts 2021-2026 – ResearchAndMarkets.com Canada Generic Drug Market Industry Trends, Share, Size, Growth, Opportunity and Forecasts 2021-2026 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Canada Generic Drug Market: Industry Trends, (..)
BioTech 365
MAY 28, 2021
Global Generic Drugs Market Report 2021: The New Generics Era – The Patent Cliff, Types of Generic Drugs, Simple Generics, Super Generics, Biosimilars, ANDA Approvals – ResearchAndMarkets.com Global Generic Drugs Market Report 2021: The New Generics Era – The Patent … Continue reading →
BioTech 365
NOVEMBER 18, 2021
Brazil Generic Drug Market (2021 to 2026) – Industry Trends, Share, Size, Growth, Forecast and Opportunities – ResearchAndMarkets.com Brazil Generic Drug Market (2021 to 2026) – Industry Trends, Share, Size, Growth, Forecast and Opportunities – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Brazil Generic (..)
NY Times
SEPTEMBER 18, 2021
Competition for market share at rock-bottom prices has led to shortages, price-spikes, allegations of price-fixing, and substandard and even dangerous practices.
BioTech 365
APRIL 26, 2021
United States Generic Drugs Market Report 2020-2026: Focus on CNS, Cardiovascular, Dermatology, Genitourinary/Hormonal, Respiratory, Anti-infective & Oncology – ResearchAndMarkets.com United States Generic Drugs Market Report 2020-2026: Focus on CNS, Cardiovascular, Dermatology, Genitourinary/Hormonal, Respiratory, Anti-infective & (..)
STAT News
MARCH 30, 2023
What happened to the market for monkeys? Are some drugs too cheap? We also discuss what leads to generic drug shortages, whether every major pharmaceutical firm needs a weight-loss drug, and what it means when drug company cancels a conference appearance. And why are biotech stocks still in the tank?
BioTech 365
APRIL 15, 2021
Global Generic Drugs (Small Molecule Generics vs Biosimilars) Market Forecast & Opportunities, 2021-2026 by Application, Drug Delivery, Form, Source, Distribution Channel – ResearchAndMarkets.com Global Generic Drugs (Small Molecule Generics vs Biosimilars) Market Forecast & Opportunities, 2021-2026 by Application, Drug Delivery, … (..)
Pharmaceutical Technology
SEPTEMBER 15, 2022
Various factors have contributed to the need and growth of API chemical suppliers such as rising healthcare expenditure, increasing disposable incomes, growing geriatric population, increasing incidence of chronic diseases, patent expiration of blockbuster drugs, increased consumption of generic drugs, and intervention of the new generation APIs.
Pharmaceutical Technology
NOVEMBER 21, 2022
Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing.
FDA Law Blog
SEPTEMBER 6, 2023
Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.
Pharmaceutical Technology
DECEMBER 20, 2022
The top 20 global biopharmaceutical companies exhibited a downward trend in aggregate market capitalisation by 9.1% This downturn in market cap was attributed to a decline in the demand for Covid-19 vaccines and therapies. Bayer recorded a negative market capitalization growth of 22.3% trillion in Q2 2022 to $3.14
Drug Patent Watch
JUNE 18, 2024
Branded generics are generic drugs that are marketed under a brand name by the manufacturer. Branded generics can be an attractive option for both consumers and pharmaceutical companies, offering cost savings while leveraging brand recognition. […] Source
Pharmaceutical Technology
MAY 16, 2023
More than half of the top 20 global biopharmaceutical companies saw a fall in market capitalisation over Q1 2023. decline in total aggregate market capitalisation from $3.61 Bayer reported the highest market capitalisation growth of 23.1% Sanofi and Regeneron’s market capitalisation grew by 12.4% This resulted in a 3.4%
Outsourcing Pharma
OCTOBER 12, 2020
Technology impacting generic drugs include artificial intelligence, telemedicine, fraud-preventing digital solutions and more, according to a report.
Pharmaceutical Commerce
FEBRUARY 9, 2024
Technavio analysis notes that an increase drug patent expirations could be a contributing factor.
Pharmaceutical Technology
NOVEMBER 21, 2022
Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing.
Fierce Pharma
NOVEMBER 22, 2023
Looking to protect its lucrative immunology drug Rinvoq, AbbVie is suing a clutch of generic drug makers that are attempting to market copycat versions of the blockbuster. |
FDA Law Blog
APRIL 2, 2024
Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”
Pharma in Brief
FEBRUARY 8, 2024
The Notice advises that if an innovative drug is categorized as “Dormant” in Health Canada’s Drug Product Database, then a generic manufacturer can compare its drug against an alternate CRP, which could include another generic drug, when filing an Abbreviated New Drug Submission ( ANDS ).
Drug Channels
MAY 2, 2023
In my most recent video webinar , I explored how the rapid expansion of patient-paid prescriptions—via cash-pay pharmacies and discount card vendors—is transforming the prescription market. Below, I follow the dollar when a patient uses a discount card to pay for a generic drug prescription. retail pharmacy pricing.
BioPharma Reporter
DECEMBER 22, 2022
Expanding generic drug competition and a decline in the demand for COVID-19 vaccines and therapies have brought down the aggregate market capitalization of the global top 20 biopharmaceutical companies by 9.1%.
Pharmaceutical Technology
APRIL 4, 2023
Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. US reliance on India for generic drugs could have supply chain security and quality implications for critical medicines.
Drug Channels
JUNE 22, 2023
In my March video webinar , I explored how the rapid expansion of patient-paid prescriptions—via cash-pay pharmacies and discount card vendors—is transforming the prescription market. Below, I follow the dollar when a patient uses a discount card to pay for a generic drug prescription. retail pharmacy pricing.
World of DTC Marketing
APRIL 12, 2021
The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Patients should be scared.
Pharmaceutical Technology
JULY 15, 2022
Nothing epitomises market failures more than the cost of insulin,” Newsom said in a video posted on Twitter. CivicaRx is a non-profit generic drug company producing affordable insulin biosimilars in collaboration with the Juvenile Diabetes Research Foundation (JDRF). In-house manufacturing the norm.
The Pharma Data
MARCH 15, 2022
Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.
Pharmaceutical Technology
MAY 31, 2023
Les Laboratoires Servier overview Les Laboratoires Servier (Servier) researches, develops, manufactures, and markets drugs for treating various diseases. The company also provides generic drugs and contract development and manufacturing services across its global network.
FDA Law Blog
MAY 25, 2022
That effort, which has most recently emerged in the forms of the “ Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 ” ( H.R. 2853 , or “BLOCKING Act”), the “ Expanding Access to Low-Cost Generics Act of 2021 ” ( S. And now there’s a report and analysis to back up that claim!
World of DTC Marketing
JUNE 22, 2022
Then there is the cost of generic drugs. A recent study in the Annals of Internal Medicine took a look at almost 90 generic drugs that the Medicare Part D program pays for, finding that Medicare could’ve saved $3.6 billion in 2020 if it had purchased 77 of 89 drugs from Cuban’s firm.
BioTech 365
MAY 18, 2021
OTC PINK:SHMN), a generic pharmaceutical, nutraceutical, and cosmeceutical company that manufactures and markets generic drugs covering … Continue reading → Chino Hills, 05/18/2021 / 15:31, CET/CEST – EQS Newswire – Sohm, Inc. CHINO HILLS, CA / ACCESSWIRE / May 18, 2021 / SOHM, Inc.
BioTech 365
JUNE 3, 2021
the “Company”) (OTC PINK:SHMN), generic Pharmaceutical, Nutraceutical, and Cosmeceutical company that manufactures and markets generic drugs … Continue reading → CHINO HILLS, CA / ACCESSWIRE / June 3, 2021 / SOHM, Inc.
Outsourcing Pharma
OCTOBER 5, 2021
The US Department of Justice reports three generic drug manufacturers have been socked with the hefty fine to resolve alleged False Claims Act violations.
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