BioPharma Drive: Drug Pricing

AUGUST 2, 2024

Adaptimmune’s Tecelra is the first TCR cell therapy to reach market and, at $727,000, is also the priciest cellular medicine for cancer in the U.S.

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BioPharma Drive: Drug Pricing

OCTOBER 13, 2023

Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.

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BioPharma Drive: Drug Pricing

AUGUST 29, 2023

A broadened clearance for Reblozyl in myelodysplastic syndromes should help Bristol Myers offset the looming loss of revenue from top-selling medicines set to soon lose market exclusivity.

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FDA Approval Disease FDA Marketing 293

Drugs.com

NOVEMBER 17, 2023

16, 2023 -- The first home test for chlamydia and gonorrhea will soon hit the market, following its approval Wednesday by the U.S. THURSDAY, Nov. Food and Drug Administration. People will be able to buy the Simple 2 Test over-the-counter at a.

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Drugs.com

MARCH 29, 2024

Food and Drug Administration warns.These creams, gels, sprays and soaps are marketed for. FRIDAY, March 29, 2024 -- Some pain-relieving skin products contain potentially harmful doses of the numbing agent lidocaine and should be avoided, the U.S.

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BioPharma Drive: Drug Pricing

AUGUST 25, 2023

market against Biogen’s inflammation-regulating medicine Tysabri. According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S.

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FDA Approval FDA Regulations Drugs 246

Drugs.com

APRIL 1, 2025

Food and Drug Administration granted marketing authorization for the first home-based, nonprescription diagnostic test for chlamydia, gonorrhea, and trichomoniasis in women, the agency announced Friday.Women with. TUESDAY, April 1, 2025 -- The U.S.

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FDA Approval FDA Marketing Drugs 216

BioPharma Drive: Drug Pricing

DECEMBER 20, 2024

The clearance of Tryngolza gives Ionis its first wholly-owned, marketed medicine. Elsewhere, Robert Temple became the latest FDA leader to leave the agency, and two biotechs cut research deals.

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The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ 2] An overview of the 3Rs The FDA and other global regulatory health authorities have long embraced the 3Rs of animal research (replace, reduce, and refine).

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BioPharma Drive: Drug Pricing

SEPTEMBER 18, 2024

The FDA’s clearance could double Kisqali’s breast cancer market. Elsewhere, Novo is exploring new ways to deliver genetic therapies and Bain is funding a growing CDMO.

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BioPharma Drive: Drug Pricing

AUGUST 5, 2023

The agency turned back the companies' attempt to also win clearance for major depressive disorder, limiting its market potential.

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FDA Approval FDA Marketing Drugs 246

Drugs.com

FEBRUARY 7, 2024

7, 2024 -- A company in Ecuador that processed the cinnamon used in flavored applesauce pouches destined for the American market is the likely source of lead contamination in those products, U.S. WEDNESDAY, Feb. investigators said.In an update to.

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Drugs.com

JUNE 13, 2023

Food and Drug Administration has approved over-the-counter marketing for the product, called Eroxon, as a. TUESDAY, June 13, 2023 -- Men with erectile dysfunction will now have the option of using a topical gel to treat the condition.

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FDA Approval FDA Production Marketing 246

BioPharma Drive: Drug Pricing

FEBRUARY 20, 2025

Layoffs at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an attorney said.

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Drug Patent Watch

OCTOBER 2, 2023

The FDA conducted a study to identify factors that may predict the likelihood of generic drug marketing applications.

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BioPharma Drive: Drug Pricing

AUGUST 15, 2024

Livdelzi, which Gilead inherited through its acquisition of CymaBay, will now compete with medicines for primary biliary cholangitis that are currently marketed by Ipsen and Alfasigma.

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BioPharma Drive: Drug Pricing

APRIL 18, 2025

regulators cleared a multiple myeloma drug GSK withdrew from market three years ago. Elsewhere, an investment firm pressed Elevation Oncology to liquidate and the FDA relaxed risk monitoring requirements for Camzyos.

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Drugs.com

JUNE 13, 2023

Food and Drug Administration has approved over-the-counter marketing for the product, called Eroxon, as a. TUESDAY, June 13, 2023 -- Men with erectile dysfunction will now have the option of using a topical gel to treat the condition.

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FDA Approval FDA Production Marketing 203

BioPharma Drive: Drug Pricing

JANUARY 21, 2025

The clearance of Datroway comes months after the companies narrowed approval plans in lung cancer and opens up a market opportunity analysts estimate to be worth about $500 million annually.

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FDA Marketing 167

BioPharma Drive: Drug Pricing

JUNE 16, 2023

The approval of Columvi adds another “bispecific antibody” to the market, highlighting the fast research progress for drugs that target two proteins rather than one.

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FDA Approval FDA Drugs Marketing 184

FDA Law Blog: Biosimilars

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In FY2023, FDA conducted over 1000 inspections under the BIMO program. We also detail some of our recommended best practices to achieve success when FDA comes knocking.

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FDA Law Blog: Biosimilars

FEBRUARY 2, 2024

Mullen — On January 31, 2024, FDA announced its intent to initiate the reclassification process for most in vitro diagnostic (IVD) products that are currently class III (high risk) into class II (moderate risk). This is to say nothing of the expected doubling of annual device submissions FDA expects it will then receive on an ongoing basis.

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FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term. does not use this term.

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Drug Patent Watch

DECEMBER 10, 2024

The Rise of Integrated CDMOs The global biotechnology and pharmaceutical services outsourcing market size was valued at $70.48 Accelerated Time to Market : By leveraging a connected network of internal experts, integrated CDMOs can help eliminate downtime, optimize processes, and minimize errors, ultimately accelerating time to market.

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BioPharma Drive: Drug Pricing

SEPTEMBER 13, 2024

Roche has now beat Merck and Bristol Myers to market with its under-the-skin immunotherapy. Elsewhere, Sanofi bought into radiopharmaceuticals and Mene Pangalos joined Biogen's board.

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Trials FDA Marketing 157

FDA Law Blog: Biosimilars

APRIL 2, 2024

Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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thought leadership

SEPTEMBER 5, 2024

Congratulations, FDA has approved your PMA! Securing a Premarket Approval (PMA) from the FDA is a significant achievement for any medical device manufacturer—a validation of your product's safety and effectiveness. But the journey doesn't end there.

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FDA Compliance Production Marketing 87

Drug Patent Watch

SEPTEMBER 12, 2024

In the labyrinthine world of pharmaceuticals, where the cost of life-saving medications can often feel like a roll of the dice, the FDA is implementing a strategy that aims to bring some much-needed transparency and affordability to the market.

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Drug Patent Watch

DECEMBER 10, 2024

Domestic Market Growth India’s domestic pharmaceutical market has consistently outpaced the overall economy, with a growth rate two to three percent higher annually. The “Ayushman Bharat Yojana” scheme, which aims to provide affordable healthcare to citizens, has further boosted the domestic market’s prospects.

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BioPharma Drive: Drug Pricing

FEBRUARY 26, 2024

The companies didn’t reveal their planned price for Simlandi, which will be the 10th Humira copycat to reach the U.S.

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FDA Approval Biosimilars FDA Marketing 157

BioPharma Drive: Drug Pricing

DECEMBER 4, 2023

Jaypirca, which has been on the market for less than a year, can now be used for more types of blood cancer but not as early as rival drugs from AbbVie and AstraZeneca.

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FDA Drugs Marketing 157

FDA Law Blog: Biosimilars

APRIL 13, 2025

The FDA emphasizes that intrahepatic bile duct cancers have an estimated 5-year relative survival rate and unresectable, locally advanced or metastatic iCCAs, such as those for which LYTGOBI is conditionally approved, is a serious public health concern where surgery is not an option and treatment for the condition involves serious risks.

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BioPharma Drive: Drug Pricing

AUGUST 14, 2023

The agency needs more time to settle with Valneva the design of a post-marketing study for the shot, which could become the first preventive therapy for chikungunya available in the U.S.

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Vaccine FDA Therapies Marketing 130

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. Significantly, FDA agrees that the RIEs may be conducted in lieu of an inspection. Raising the question: how does FDA define “all parties?”

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BioPharma Drive: Drug Pricing

JULY 3, 2024

Elsewhere, Vertex got an FDA decision date for its “vanza triple” and Dupixent won a marketing green light in Europe for COPD. Forbion led the startup’s Series B round.

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Therapies FDA Marketing 150

Conversations in Drug Development Trends

AUGUST 23, 2023

However, patients also play a vital role in engaging directly with the FDA. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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Drug Patent Watch

FEBRUARY 3, 2021

Abstract Biosimilar medicines expand the biotherapeutic market and improve…. The post The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA appeared first on DrugPatentWatch - Make Better Decisions.

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