BioPharma Reporter

APRIL 21, 2022

Last week saw the US Food and Drug Administration (FDA) approve the Biologics License Application (BLA) from Amneal Pharmaceuticals Inc for bevacizumab-maly, a biosimilar referencing Avastin, the Roche/Genentech product.

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Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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pharmaphorum

AUGUST 24, 2021

One of the most common and challenging side effects for people undergoing dialysis for chronic kidney disease – chronic itching – now has an FDA-approved treatment.

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The Pharma Data

MAY 13, 2021

Biogen licenses a stroke drug from Japanese drugmaker TMS ( BioPharmaDive ). ICER, Accelerated Approval And The Payer Voice At The US FDA ( Pink Sheet ). ‘Imminent’ Generic Approvals Expected To Help US FDA Meet On-Time Review Metric Retroactively ( Pink Sheet ).

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Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. The exact same FDA-approved drugs are sold in America and other countries, but with different labels.

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pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Novartis resubmitted its marketing application in the US earlier this year, after swapping fill-and-finish production to one of its own facilities in Schaftenau, Austria.

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pharmaphorum

APRIL 6, 2022

The EU regulator has started a review of Novartis’ PD-1 inhibitor tislelizumab – licensed from Chinese biotech BeiGene – for oesophageal and lung cancers, ahead of an FDA decision on the drug due in July. FDA clears Vijoice for rare overgrowths.

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FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. After all, it never invested the time and resources necessary to obtain approval for commercial marketing or use. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. Men in Black from the PTO’s PTE branch might have gotten to us. Lehman , No.

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pharmaphorum

MAY 25, 2022

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder.

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pharmaphorum

JANUARY 5, 2023

The deal centres on reSET and reSET-O, Pear’s cognitive behavioural therapy (CBT) based programmes, for people living with substance and opioid use disorders, respectively, which have been approved by the FDA as an adjunct to outpatient treatment. Pear secured approval for reSET-O in the following year.

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The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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pharmaphorum

DECEMBER 14, 2020

Ruxolitinib is already FDA approved under the brand name Jakafi to treat the bone marrow diseases myelofibrosis, polycythemia vera and graft-versus-host disease. Originally developed by Incyte, Novartis licensed in the drug for development and marketing outside the US.

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XTalks

MAY 28, 2024

Through their insights, we gain a clearer understanding of the strategic decisions that go into vaccine development and deployment, the anticipated impacts on the market and the ongoing efforts to enhance community health resilience against influenza.

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pharmaphorum

MAY 24, 2021

While there are plenty of EGFR-targeting drugs on the market for NSCLC, Rybrevant is the first to be FDA-approved for patients with exon 20 mutations, and also represents Janssen’s first lung cancer therapy. Two thirds of them had a response that lasted for at least six months.

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pharmaphorum

DECEMBER 21, 2021

BeiGene was also the developer of Novartis’ PD-1 inhibitor tislelizumab , which was filed for FDA approval in September as a second-line treatment for oesophageal cancer. Novartis licensed rights to tislelizumab for $650 million upfront and up to $1.55

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1.

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pharmaphorum

JUNE 2, 2021

US marketing application. The additional capacity will also allow Moderna to prepare for full regulatory approval of the vaccine, which would be its first registered product and likely a source of blockbuster revenue in the coming years as COVID-19 switches from pandemic to endemic status.

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XTalks

DECEMBER 29, 2022

This highlights potentially new marketing trends that life science companies may have to start looking into if they haven’t already. As of December 16, 2022, there are seven US Food and Drug Administration (FDA) approved gene therapies. In 2023, a number of gene therapies are expected to get the FDA green light.

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XTalks

APRIL 24, 2023

The Recent Increase in Cellular and Gene Therapy Product Approvals for Rare Diseases As of December 2022, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cellular and gene therapy products. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.

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FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.

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Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group. What are the risks?

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The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. billion during 2019-2023 (Technavio 2019).

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The Pharma Data

NOVEMBER 5, 2020

resolving patent litigation brought in response to Teva’s Abbreviated New Drug Application, seeking approval to market a generic version of Xtampza ER prior to the expiration of Collegium’s applicable patents. FDA approval, and customary exceptions). Reached a settlement with Teva Pharmaceutical USA, Inc.

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The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. When Lucentis ® (Ranibizumab) received FDA approval in late June 2006, the new macular degeneration drug was celebrated as a major medical breakthrough.

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The Pharma Data

JANUARY 21, 2021

ViiV Healthcare is the marketing authorization holder for CABENUVA. Janssen is the marketing authorization holder for EDURANT ® in the U.S. Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. In the U.S.,

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XTalks

JUNE 12, 2023

Other approvals included the Intellis rechargeable neurostimulator for treating chronic pain associated with diabetic peripheral neuropathy (DPN). Medtronic’s Hugo Robotic-Assisted Surgery system , released in a limited market in June 2021, has been receiving positive reviews for its performance in various surgeries.

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pharmaphorum

DECEMBER 8, 2020

The company says in its IPO prospectus that it plans to list its shares on the Nasdaq Global Market under the ABCL ticker. Its approach involves licensing rights to the antibodies to other pharma companies, rather than bringing its own candidates through development.

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XTalks

SEPTEMBER 17, 2020

Often, the potential patient pool for a given trial is small and the unmet need is high, incentivizing drugmakers and regulators to find innovative ways to make game-changing therapeutics available to those who need them most. Nizoral is prescribed off-label, while the others are FDA approved. Paget’s Disease.

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The Pharma Data

AUGUST 3, 2021

Selling, General & Administrative (SG&A) expenses increased 7% driven by marketed product support due to increased customer engagement in response to the pandemic recovery and investment in new product launches. LUMAKRAS received accelerated approval based on overall response rate and duration of response. In May, the U.S.

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XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. The FDA approved the drug over a decade ago in September 2009.

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The Pharma Data

JANUARY 9, 2021

We are proud to be a leader in the growing public health threat market, enabled by our development and manufacturing expertise, successful public-private partnerships, and broad portfolio of products and CDMO services. “Operationally, we rapidly responded to our customers’ needs, and financially, we delivered record revenue and earnings.

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Pfizer

JANUARY 27, 2023

and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. It is important to note that these studies are required by U.S. and around the world. INDICATION & AUTHORIZED USE Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

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FDA Law Blog

JANUARY 18, 2024

Rescheduling Analyses, 2016 DEA noted in 2016 that a drug had a currently accepted medical use for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) under the Federal Food, Drug and Cosmetic Act. FDA, Basis for the Recommendation to Reschedule Marijuana Into Schedule III of the Controlled Substances Act, 3.

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The Pharma Data

AUGUST 6, 2020

Marketing, selling and administrative expenses increased 51% to $1.6 Cash, cash equivalents and marketable debt securities were $22.2 This approval was based on the Phase 3 CheckMate -9LA study. This approval was based on data from Part 1a of the Phase 3 Checkmate -227 study. billion, or $1.63 billion, or $1.18

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Pharmacy Checkers

DECEMBER 12, 2019

Testimony this week by the Government Accountability Office before the House Energy and Commerce Subcommittee on Oversight and Investigations about the FDA’s potential failures to protect the public health may not take you into such a totally lopsided universe, but it shows that things may not be so golden. What about other countries?

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Camargo

FEBRUARY 4, 2021

Pfizer’s Xalkori (crizotinib) was approved in 2011 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase (ALK)-positive. FDA Threatens to Withdraw Standard of Care Due to Post-Approval Study Failure. Contact us to find out how we can support your program.

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