New Drug Approvals

JUNE 11, 2025

2] Gepirone was synthesized by Bristol-Myers Squibb in 1986 and was developed and marketed by Fabre-Kramer Pharmaceuticals. [4] Archived from the original (PDF) on 18 February 2019. Jump up to: a b c d e “Gepirone – Fabre-Kramer Pharmaceuticals” AdisInsight. July 2019). 1] It is taken orally. [1]

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DrugBank

JUNE 18, 2025

While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. This means pharmaceutical companies must remain vigilant and adaptable to comply with evolving regulations. The extensive data requirements for regulatory submissions further complicate the process.

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Drug Target Review

JUNE 2, 2025

Since 2019, Bertholjotti has played a pivotal role in steering the commercial development of Lonzas bioconjugates sector. With a deep understanding of the industry’s complexities and the evolving market needs, he has been instrumental in providing innovative solutions for both biotech startups and large pharmaceutical companies.

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New Drug Approvals

APRIL 25, 2025

“An Overview of Bioactive 1,3-Oxazole-Containing Alkaloids from Marine Organisms” Pharmaceuticals. Han C, Kelly SM, Cravillion T, Savage SJ, Nguyen T, Gosselin F (2019). 20 May 2019. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84” WHO Drug Information.

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Drug Target Review

MARCH 3, 2025

However, promising pilot data from ongoing collaborations with pharmaceutical companies suggest that brain organoids are set to become a valuable tool in preclinical research. In 2019, Jens co-founded OrganoTherapeutics SARL, where he currently serves as CEO.

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New Drug Approvals

JUNE 15, 2025

“International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80” WHO Drug Information. 24 September 2024. . ^ “EU/3/22/2650: Orphan designation for the treatment of myasthenia gravis” European Medicines Agency. 15 September 2023. Archived from the original on 29 January 2023.

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New Drug Approvals

APRIL 18, 2025

potassium hydroxide), and water to prepare 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-prop-2-ynyl-1,3-thiazol-2-amine (Compound 1) or a pharmaceutically acceptable salt thereof is provided below in Scheme VII. World Health Organization (2019). Neurocrine Biosciences.

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New Drug Approvals

APRIL 19, 2025

0004]The synthesis of Landiolol 1 is disclosed in US 5013734 , JP 3302647 , CN 100506814 , JP 2539734 and Chemical & Pharmaceutical Bulletin 1992, 40 (6) 1462-1469. “Development of a highly cardioselective ultra short-acting beta-blocker, ONO-1101” Chemical & Pharmaceutical Bulletin. June 1992). 40 (6): 14629.

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Drug Patent Watch

DECEMBER 18, 2024

As a business professional in the pharmaceutical industry, understanding and implementing effective strategies for drug patent prosecution can be the difference between market domination and missed opportunities. Dr. Jane Smith, a patent attorney specializing in pharmaceuticals, advises: “File early and file often. billion[1].

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

Permission granted by Incyte Dive Brief: Incyte has named veteran pharmaceutical executive Bill Meury as its new CEO, replacing longtime head Hervé Hoppenot, who led the cancer and blood disease drugmaker for the past 11 years. On June 26, 2025, the company announced the replacement of longtime CEO Hervé Hoppenot with Bill Meury.

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DrugBank

OCTOBER 4, 2024

Deal Structuring Deal structuring in pharmaceutical M&A requires a balance of financial, legal, and strategic considerations. Intellectual Property Valuation Valuing intellectual property (IP) assets is a critical component of pharmaceutical M&A, as these assets often represent a significant portion of a company's value.

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Creative Biolabs

JANUARY 15, 2020

Drug Name Trade Name Company Approval Date 1 PrabotulinmtoxinA Jeuveau Evolus 2019/2/1 2 Caplacizumab-yhdp Cablivi Ablynx 2019/2/6 3 Triclabendazole Egaten Novartis 2019/2/13 4 Brexanolone Zulress Sage Therapeutics 2019/3/19 5 Solriamfetol Sunosi Jazz Pharmaceuticals 2019/3/20 6 Siponimod Mayzent Novartis 2019/3/26 7 Romosozumab-aqqg Evenity Amgen (..)

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Antidote

JULY 29, 2022

In 2019 alone, research and development spending totaled $186 billion for the global pharmaceutical industry. Between 2009 and 2018, U.S. biopharmaceutical companies spent about $1 billion per drug according to an analysis published in JAMA , and other studies have found that it can cost up to $2.8

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National Drug & Alcohol Research Centre Blog

DECEMBER 4, 2023

In Australia, both methadone and buprenorphine have been subsidised by the Pharmaceutical Benefit Scheme (PBS) for the treatment of opioid dependence (termed ‘opioid agonist treatment’ or OAT) for several decades. In September 2019, a new formulation of long-acting injectable buprenorphine became available on the PBS.

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Drug Channels

SEPTEMBER 1, 2020

This week, I’m rerunning some popular posts while I work on the forthcoming 2020-21 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. For 2019, we again aim our magnifying glass at the annual trend reports from the largest pharmacy benefit managers (PBMs): CVS Health, Express Scripts, and Prime Therapeutics.

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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

Karst — If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda Pharmaceuticals, Inc. VANDA PHARMACEUTICALS, INC. VANDA PHARMACEUTICALS, INC. 24-270 VANDA PHARMACEUTICALS, INC. 23-5200 (D.C.

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The Pharma Data

NOVEMBER 3, 2020

03, 2020 (GLOBE NEWSWIRE) — Bellicum Pharmaceuticals , Inc. The securities described above were offered by Bellicum pursuant to a shelf registration statement filed by Bellicum with the Securities and Exchange Commission (SEC), which was declared effective on July 30, 2019. About Bellicum Pharmaceuticals. HOUSTON, Nov.

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The Pharma Data

NOVEMBER 4, 2020

–( BUSINESS WIRE )– Concert Pharmaceuticals, Inc. President and Chief Executive Officer of Concert Pharmaceuticals. million as of December 31, 2019. million for the same period in 2019. million for the same period in 2019. per share, for the quarter ended September 30, 2019.

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Drug Patent Watch

JULY 25, 2024

This chart shows the generic pharmaceutical companies that had the most successful drug patent challenges from 2019 to 2024. Companies that successfully challenge patents on branded drugs are granted…

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The Pharma Data

DECEMBER 10, 2020

11, 2020 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. About Lexicon Pharmaceuticals. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission. Source link.

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The Pharma Data

OCTOBER 26, 2020

27, 2020 /PRNewswire/ — Aridis Pharmaceuticals, Inc. Dr. Hasan Jafri , Chief Medical Officer of Aridis Pharmaceuticals, will be a speaker on a panel entitled “Direct Antivirals and Other Agents Against SARS-CoV2 Virus.” About Aridis Pharmaceuticals, Inc. Aridis Pharmaceuticals, Inc. SAN JOSE, Calif. ,

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The Pharma Data

JANUARY 27, 2021

27, 2021 — The number of adverse drug reactions (ADRs) associated with hydroxychloroquine and chloroquine more than doubled in 2020 compared with 2018 and 2019, according to a research letter published online Jan. percent in 2018 and 2019, respectively. percent in 2018 and 2019, respectively. WEDNESDAY, Jan. Overall, 97.1

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The Pharma Data

NOVEMBER 19, 2020

19, 2020 — The volume of transcatheter aortic valve replacement (TAVR) procedures in the United States increased from 2011 to 2019, exceeding surgical aortic valve replacements in 2019, and 30-day mortality and stroke rates have decreased since 2011, according to a study published in the Nov. THURSDAY, Nov. Carroll, M.D.,

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The Pharma Data

APRIL 1, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced the completion of its previously-announced sale of Takeda Consumer Healthcare Company Limited (“TCHC”) to Oscar A-Co KK, a company controlled by funds managed by The Blackstone Group Inc. Ltd (“Alinamin Pharmaceuticals”). billion in fiscal year 2019.

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Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

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The Pharma Data

NOVEMBER 5, 2020

05, 2020 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today reported its financial results for the quarter ended September 30, 2020 and provided a corporate update. million for the 2019 Quarter and $44.5

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Policy Prescription

AUGUST 25, 2022

His essential focus was that the EU does not have the same strong pharmaceutical regulations as the U.S. In 2019, years ago still, the highly-respected European Medicines Agency, with recognition by the FDA, announced that the EU and US reached “a milestone in mutual recognition of inspections of medicines manufacturers.”.

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Drug Target Review

MARCH 28, 2024

In short, this hypothesis underscores the potential benefits of aligning pharmaceutical development more closely with nature. He was an early employee of Recursion Pharmaceuticals, where he scaled their high-content imaging platform by multiple orders of magnitude before joining Enveda in 2021. References Newman DJ, Cragg GM.

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The Pharma Data

JULY 22, 2021

This transaction continues Sanofi’s ongoing strategic transformation announced in December 2019. Septodont is a leading manufacturer of dental pharmaceuticals and medical devices. The agreement covers the registrations, trademarks, and related commercial rights. This is an asset deal. No employees, equipment or real estate is included.

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The Pharma Data

NOVEMBER 23, 2020

have partnered with Yangtze River Pharmaceutical Group, a leading Chinese pharmaceutical company, to form an exclusive strategic partnership for the commercialization of eight biosimilar medicines in China. CAHT was founded in March 2019 as a joint venture between Alvotech and CCHT, Changchun, China. Ltd (CAHT).

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The Pharma Data

JANUARY 13, 2021

“Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: [link]. Source link.

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New Drug Approvals

AUGUST 21, 2023

4] [5] History Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to Clementia Pharmaceuticals from Roche Pharmaceuticals. 21] Phase III In December 2019, Ipsen issued a partial clinical hold for people under the age of 14, due to reports of early fusion of growth plates. [22] Clementia Pharmaceuticals.

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The Pharma Data

OCTOBER 15, 2020

Dr Carl Firth, Chief Executive Officer , ASLAN Pharmaceuticals, said : “ Following our review of the data we have generated on ASLAN003 and discussions with experts in the field , we believe ASLAN003 has a potential best in class profile as the most potent oral DHODH inhibitor targeting autoimmune indications. SINGAPORE, Oct.

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The Pharma Data

DECEMBER 9, 2020

EDISON, NJ / ACCESSWIRE / December 10, 2020 / Hepion Pharmaceuticals, Inc. ” About Hepion Pharmaceuticals. Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for the treatment of non-alcoholic steatohepatitis (NASH) and other liver diseases. Source link.

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Drug Channels

JULY 29, 2020

We are offering our 2019–20 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors at discounts up to 35% off. Sale prices valid thru September 8, 2020. The updated 2020-21 edition will be available in October 2020.

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NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

Science Translational Medicine, 2019 Researchers continue to produce impressive miniature human tissues that resemble the structure of a range of human organs, including the livers, kidneys, hearts, and even the brain. The two were challenged by their Swiss colleagues at Roche Pharmaceuticals to create a leukemia-on-a-chip model.

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The Pharma Data

JANUARY 3, 2021

04, 2021 (GLOBE NEWSWIRE) — TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, announced today that its subsidiary, InspirMed Inc., SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Jan.

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