The Pharma Data

JANUARY 5, 2021

Durham, North Carolina-based Ribometrix announced a strategic collaboration deal with Genentech , a Roche company, to identify and advance novel RNA-targeted small molecule therapeutics. This is because many proteins do not have small-molecule binding sites. This is not the first deal for RNA therapeutics for Genentech.

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The Pharma Data

OCTOBER 26, 2020

27, 2020 /PRNewswire/ — Aridis Pharmaceuticals, Inc. ” Panel: Direct Antivirals and Other Agents Against SARS-CoV2 Virus Date: Wednesday, October 28, 2020 Time: 10:30AM- 11:50AM ET. AR-711 is an in-licensed mAb that is directed against the receptor binding domain of the SARS-Cov 2 virus.

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The Pharma Data

MAY 7, 2021

under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S.

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The Pharma Data

NOVEMBER 4, 2020

5, 2020 11:00 UTC. NASDAQ: CNCE) today reported financial results for the third quarter of 2020. Our team has diligently and effectively executed on our plan, and I’m pleased that we have achieved our stated 2020 pipeline milestones. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. LEXINGTON, Mass.–(

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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

MAY 6, 2021

This donation of the vaccine is another tool in our toolbox of measures to help make the Olympic and Paralympic Games Tokyo 2020 safe and secure for all participants and to show solidarity with our gracious Japanese hosts,” said IOC President Thomas Bach. “We The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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The Pharma Data

DECEMBER 13, 2020

14, 2020 (GLOBE NEWSWIRE) — Relay Therapeutics, Inc. RLY-1971 is a potent small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2). . Relay Therapeutics to host conference call at 8:00 a.m. CAMBRIDGE, Mass., About RLY-1971.

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The Pharma Data

NOVEMBER 11, 2020

12, 2020 14:00 UTC. As an orally bioavailable small molecule with broad antiviral activity, SLV213 could be a valuable treatment to meet today’s urgent need to fight COVID-19 as well other life-threatening infectious diseases, such as Chagas disease, Ebola virus disease, and Nipah virus infection.”. About SLV213.

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The Pharma Data

OCTOBER 18, 2020

19, 2020 08:02 UTC. Inflection Biosciences Ltd is developing small molecule therapeutics for the treatment of cancer. The company’s pipeline was licensed from the Spanish National Cancer Research Centre (CNIO). Berk, MD, to its Board of Directors. About Inflection Biosciences.

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The Pharma Data

NOVEMBER 18, 2021

— Gilead Exercises Options to Arcus’s Anti-TIGIT Program (Domvanalimab and AB308), Etrumadenant (A2a/A2b Adenosine Receptor Antagonist) and Quemliclustat (Small Molecule CD73 Inhibitor) — — Arcus to Receive Option Payments Totaling $725 million — Gilead Lores,Inc. Nasdaq GILD) and Arcus Biosciences,Inc.

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The Pharma Data

NOVEMBER 8, 2020

9, 2020 /PRNewswire/ — Solid 9M business performance despite COVID-19 and generic Aczone challenges: Net Sales €613.8 Based on the solid year to date performance Almirall is reiterating its guidance for FY 2020. YTD September 2020. BARCELONA, Spain , Nov. MM (-3.7%; +4.3%

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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. mL) in addition to Original Concentration Humira.”

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The Pharma Data

DECEMBER 15, 2020

In late 2020, the effort received $200,000 in seed funding from the Baker Department of Cardiometabolic Health at the University of Melbourne’s medical school. Small Molecule Inhibitors. NMD670 is a first-in-class small molecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel.

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The Pharma Data

DECEMBER 11, 2020

Friday, December 11, 2020. Government to supply doses in 2020 & 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. In July 2020, Pfizer and BioNTech announced an agreement with the HHS and the DoD to meet the U.S.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. CHATHAM, N.J., 1 Noyce RS, et al.

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The Pharma Data

SEPTEMBER 9, 2020

The proposed agreement is intended to provide a supply of 200 million doses and an option to purchase additional 100 million doses, with deliveries starting by the end of 2020, subject to regulatory approval. Deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization.

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The Pharma Data

SEPTEMBER 12, 2020

Pfizer Disclosure Notice: The information contained in this release is as of September 12, 2020. For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC’s website at www.sec.gov.

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The Pharma Data

DECEMBER 12, 2020

12, 2020– AstraZeneca and Alexion Pharmaceuticals, Inc. AstraZeneca has developed a broad range of technologies, initially focused on small molecules and biologics and with a growing focus in precision medicine, genomics, oligonucleotides and epigenetics. As of 30 September 2020 , Alexion had gross assets of $17.5bn.

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The Pharma Data

JANUARY 10, 2021

2020 was a remarkable year of progress for Ascendis reflecting the dedication and commitment of our employees worldwide as we made meaningful strides to achieve our vision, and meet or accelerate completion of our key milestones,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. . .

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The Pharma Data

NOVEMBER 5, 2020

. Trading under “OCUP” on the Nasdaq Capital Market to begin November 6, 2020. Conference Call and Live Webcast on Friday, November 6, 2020, at 11 AM Eastern Time. 05, 2020 (GLOBE NEWSWIRE) — Ocuphire Pharma, Inc. , Concurrent $21.15 FARMINGTON HILLS, Mich.,

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The Pharma Data

SEPTEMBER 9, 2020

Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

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The Pharma Data

NOVEMBER 20, 2020

. Based on current projections, the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Friday, November 20, 2020 — Pfizer Inc. by the middle to end of December 2020. Germany, Turkey, South Africa, Brazil and Argentina.

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The Pharma Data

AUGUST 20, 2020

These results informed the selection of the BNT162b2 candidate for the pivotal Phase 2/3 global study in up to 30,000 participants that started in July 2020, which has to date enrolled more than 11,000 participants, including in areas with significant SARS-CoV-2 transmission. The information contained in this release is as of August 20, 2020.

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The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

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The Pharma Data

NOVEMBER 9, 2020

NEW YORK & MAINZ, GERMANY–(BUSINESS WIRE) November 9, 2020. Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 The information contained in this release is as of November 9, 2020. Submission for Emergency Use Authorization (EUA) to the U.S.

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The Pharma Data

DECEMBER 1, 2020

2, 2020 07:05 UTC. In July 2020, Pfizer and BioNTech announced an agreement with the U.K. The delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts. Pfizer Disclosure Notice.

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The Pharma Data

NOVEMBER 15, 2020

R&D collaboration building on Lead Pharma’s expertise in the discovery, design and optimization of small molecule treatments. Lead Pharma may receive payments of up to €260 million plus royalties on sales. OSS, Netherlands , Nov. OSS, Netherlands , Nov.

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New Drug Approvals

SEPTEMBER 29, 2024

link] 01 Aug 2022 Cortexyme is now called Quince Therapeutics You need to be a logged in or subscribed to view this content This small molecule is an orally available protease inhibitor targeting the lysine proteases of the periodontal pathogen Porphyromonas gingivalis. Cortexyme’s approach is based on the theory that P.

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The Pharma Data

AUGUST 3, 2021

Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development. ” $ in millions, exceptper share data Second Quarter % 2021 2020 Change Revenue $ 6,740.1 $ 5,499.4 on a reported basis and increased to $1.87 on a non-GAAP basis.

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The Pharma Data

NOVEMBER 29, 2020

29, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), ” “The emergence of the PROTAC technology represents another breakthrough in the identification of small molecule drugs. Small-molecule inhibitors of the MDM2-p53 protein-protein interaction (MDM2 inhibitors) in clinical trials for cancer treatment.

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The Pharma Data

NOVEMBER 22, 2020

In parallel, Cytokinetics plans to conduct commercial readiness assessments and to evaluate potential partnering opportunities, including co-promotion options in North America as well as licensing in other territories. An archived replay of the webcast will be available via Cytokinetics’ website until December 7, 2020.

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The Pharma Data

JANUARY 17, 2021

“People living with LN are in need of an advanced therapy that quickly drives the disease into remission and mediates kidney damage,” said Peter Greenleaf, president and chief executive officer of Aurinia, in July 2020 when the FDA accepted the NDA to review. “We As a result, it stabilizes the podocyte in the kidney.

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The Pharma Data

DECEMBER 10, 2020

Thursday, December 10, 2020 – . Based on a data cut-off date of October 9, 2020, 37,706 participants had a median of at least two months of safety data available after dose 2 and contributed to the main safety dataset. The information contained in this release is as of December 10, 2020. Pfizer Disclosure Notice.

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Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. See AgencyIQ’s analysis of these changes here.

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The Pharma Data

MARCH 4, 2021

Takeda and Ovid reported results from the Phase 2 ELEKTRA study in August 2020, in which soticlestat met its primary endpoint of reducing seizure frequency in pediatric patients with DS or LGS. Advancing New Treatment Options for DS and LGS Patients. selective GABA A receptor agonist.

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The Pharma Data

AUGUST 3, 2021

billion in comparison to the second quarter of 2020, driven by higher unit demand, partially offset by lower net selling prices. billion in the second quarter of 2020 driven by a difference in the timing of tax payments. Total product sales increased 3% for the second quarter of 2021 versus the second quarter of 2020.

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The Pharma Data

DECEMBER 27, 2020

28, 2020 04:00 UTC. BRUKINSA for patients with relapsed/refractory (R/R) Waldenström’s macroglobulinemia (WM) (accepted in October 2020, under priority review). BRUKINSA for patients with relapsed/refractory (R/R) Waldenström’s macroglobulinemia (WM) (accepted in October 2020, under priority review).

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