The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. 20, 2020 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada.

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The Pharma Data

OCTOBER 21, 2020

22, 2020 (GLOBE NEWSWIRE) — Nevakar Inc. , a biopharmaceutical company developing multiple assets in the ophthalmic and injectable areas, announced today it received approval from the U.S. Food and Drug Administration (FDA) to market Ephedrine Sulfate Injection in a ready-to-use 50mg/10 ml single use vial presentation.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Haematologica.

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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. “In FDA approval, and customary exceptions).

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The Pharma Data

DECEMBER 9, 2020

10, 2020 08:00 UTC. –( BUSINESS WIRE )– Advanced Bionics (AB) , a global leader in cochlear implant technology, in collaboration with Phonak, a leading provider of life-changing hearing solutions, receives FDA approval and announces it is bringing Marvel hearing technology to Advanced Bionics cochlear implant wearers.

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The Pharma Data

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — CNS Pharmaceuticals, Inc. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. . HOUSTON , Dec. One patient experienced a durable complete response and remains cancer-free as of Feb.

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The Pharma Data

JANUARY 18, 2021

FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving the panels for more problematic applications, according to Prevision Policy, a Washington, D.C.-based based research firm.

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The Pharma Data

NOVEMBER 5, 2020

5, 2020 /PRNewswire/ — Third quarter 2020 revenues increased 32% to $2.29 Third quarter 2020 EYLEA ® U.S. Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07 Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07

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The Pharma Data

FEBRUARY 4, 2021

3, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) announced financial results for the fourth quarter and full year ended December 31, 2020. AbbVie hosted an Immunology Strategic Update event on December 14, 2020 for members of the investment community. NORTH CHICAGO, Ill., Gonzalez , chairman and chief executive officer, AbbVie.

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The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. NASDAQ:ALXN) today announced financial results for the third quarter of 2020. Non-GAAP diluted EPS for the third quarter of 2020 was $3.24 , a 16 percent increase versus the third quarter of 2019. ” Third Quarter 2020 Financial Highlights. in the prior year.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). TOKYO and CAMBRIDGE, England , Dec.

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The Pharma Data

DECEMBER 20, 2020

Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. It was approved on December 15, 2020. The FDA completed a class 2 response in July 2020. Here’s a look.

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa. and CHICAGO , Oct.

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New Drug Approvals

DECEMBER 19, 2022

2020 Feb 27;63(4):1612-1623. Epub 2020 Feb 12. 1] Olutasidenib was approved for medical use in the United States in December 2022. [1] 1] Olutasidenib was approved for medical use in the United States in December 2022. [1] Olutasidenib FT-2102 FT2102 C 18 H 15 ClN 4 O 2 354.79 J Med Chem. doi: 10.1021/acs.jmedchem.9b01423.

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The Pharma Data

DECEMBER 16, 2020

17, 2020 09:00 UTC. NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. VICTORIA, British Columbia & ROCKVILLE, Md.–(

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The Pharma Data

OCTOBER 29, 2020

Data support baricitinib’s ongoing Phase 3 program and potential to be the first approved medicine for people living with alopecia areata (AA). . Baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte. 1 Olumiant Prescribing Information, 2020. J Rheumatol.

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The Pharma Data

JULY 29, 2021

Mepolizumab was approved for use in HES in the US in September 2020, followed by Brazil in February 2021 and Argentina in May 2021. It is not currently approved for use in COPD anywhere in the world. The following information is based on the US Prescribing Information for Nucala in licensed indications only.

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The Pharma Data

JANUARY 9, 2021

Reports preliminary 2020 total revenues of $1.55 billion at the midpoint and Adjusted EBITDA of $635 million at the midpoint, both at or above prior guidance given in November 2020. NYSE:EBS) today announced its financial forecast for 2021 and selected preliminary unaudited financial results for 2020.

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The Pharma Data

AUGUST 17, 2021

Lyumjev, a novel formulation of insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce A1C levels, was approved by the FDA in June 2020. Lyumjev ® and Humalog ® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

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The Pharma Data

NOVEMBER 4, 2020

Total Revenue Increased 39% in Third Quarter 2020 and 56% in First Nine Months of 2020 Compared toSame Periods of 2019 Despite COVID-19 Headwinds. Progress Continues Towards VASCEPA® (icosapent ethyl) Approval and Commercialization in Europe. Key A chievements in Third Quarter 2020 (and recent weeks).

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The Pharma Data

NOVEMBER 22, 2020

Blueprint Medicines had a target action date of November 23, 2020 for pralsetinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC). The FDA approved it under the brand name Gavreto on September 4. The drug was approved for that indication on November 13.

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The Pharma Data

JANUARY 21, 2021

.” The once-monthly rilpivirine and cabotegravir injectable treatment was approved by Health Canada on March 20, 2020, and the European Commission approved a once-monthly and once every two-month version of the injectable treatment on December 21, 2020.

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New Drug Approvals

SEPTEMBER 8, 2024

1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] 5] The FDA granted the application for palopegteriparatide orphan drug and priority review designations. [5] 19 October 2020. Food and Drug Administration (FDA) (Press release).

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New Drug Approvals

SEPTEMBER 10, 2024

Deuruxolitinib C 17 H 18 N 6 , 314.422 Fda approved Leqselvi , 7/25/2024, To treat severe alopecia areata C-21543, CTP 543, CTP-543, CTP543 (3r)-3-(2,2,3,3,4,4,5,5-d8)cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile 1h-pyrazole-1-propanenitrile,beta.-(cyclopentyl-2,2,3,3,4,4,5,5-d8)-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,

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The Pharma Data

NOVEMBER 9, 2021

TERMS OF THE ARRANGEMENT Biohaven and Pfizer are entering into a collaboration and license agreement and affiliated sublicense agreement pursuant to which Pfizer will acquire rights to manipulate rimegepant and zavegepant outside of theU.S. Rimegepant was approved by theU.S. and coequals outside theU.S.,

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Codon

JULY 14, 2024

Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks. Hemopure, the only FDA-approved HBOC product, is a bovine hemoglobin that is chemically crosslinked (that is, several hemoglobin molecules are bound to each other) to improve its stability.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. 9,273,141 was submitted on September 18, 2020 (Docket No.

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The Pharma Data

NOVEMBER 29, 2020

Y-mAbs Therapeutics has a target action date of November 30 for its Biologics License Application (BLA) for Danyelza (naxitamab) for patients with relapsed/refractory high-risk neuroblastoma. The drug was developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs.

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The Pharma Data

APRIL 8, 2021

This Phase 3 study of 1,525 patients began in June 2020 and enrolled hospitalized patients who did not require supplemental oxygen (ordinal scale [OS] 4), required supplemental oxygen (OS 5) or high-flow oxygen/non-invasive ventilation (OS 6). ACTT-2 began in May 2020 and has published results from 1,033 patients.

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New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] April 2020). 1] It is taken by mouth. [1] PMC 9313037. PMID 35885040.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

But in 2020, a Citizen Petition came along looking to upend FDA’s approach to strength. Boehringer Ingelheim submitted a Citizen Petition in December 2020 encouraging FDA to interpret the term “strength” under the BPCIA differently than the Agency does under the Hatch-Waxman Act.

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The Pharma Data

APRIL 26, 2022

Veklury was approved by the FDA in October 2020, for adults and pediatric patients 12 years of age and older and weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization. These licenses currently remain royalty-free, reflecting Gilead’s existing commitment to enabling broad patient access to remdesivir.

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The Pharma Data

AUGUST 3, 2021

For more information about the authorized use of baricitinib in COVID-19 and mandatory requirements of the EUA, please see the FDA Letter of Authorization , Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers ( English ) ( Spanish ). It is approved in the U.S. Serious Side Effects.

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The Pharma Data

NOVEMBER 2, 2020

Based Testing at FDA & CLIA Certified Lab. LOS ANGELES, CA / ACCESSWIRE / November 3, 2020 / Decision Diagnostics Corp. Company Continues to Seek Global Distribution Agreements Across All Continents As It Makes Progress With Its U.S.- today announced it has signed distribution agreements for its GenViro!

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The Pharma Data

JANUARY 5, 2021

As part of this transaction, the Company expects to take a one-time charge of up to $16 million in the fourth quarter of 2020. based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C.

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The Pharma Data

NOVEMBER 26, 2020

27, 2020 /PRNewswire/ — Protalix Biotherapeutics, Inc. The FDA extended the PDUFA action date by three months to April 27, 2021, from January 27, 2021. Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. .

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