The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

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The Pharma Data

JANUARY 22, 2021

22, 2021 — The U.S. Food and Drug Administration approved the first monthly injectable, complete regimen for HIV-infected adults, the agency announced Thursday. Approval of Cabenuva and Vocabria was granted to ViiV Healthcare. © 2021 HealthDay. Posted: January 2021. FRIDAY, Jan. More Information.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. in the first quarter of 2021. BOSTON, Nov. Source link.

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The Pharma Data

JANUARY 11, 2021

12, 2021 /PRNewswire/ — MicroVention, Inc., based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. .

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The Pharma Data

OCTOBER 30, 2020

Dive into this week’s update for more details on the actions taken by the FDA in the ongoing response to the Covid-19 pandemic. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.

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The Pharma Data

JANUARY 22, 2021

22, 2021 — The first monthly shots to treat adults with HIV were approved by the U.S. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” said Dr. The company said that is “within the range” of what one-a-day pill combos cost.

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The Pharma Data

AUGUST 7, 2021

As part of our commitment to ensure treatment access and affordability for innovative therapies, Sanofi has decided to price Nexviazyme the same as alglucosidase alfa, the only other FDA-approved therapy for the treatment of Pompe disease and the comparator arm in the pivotal study. Source link: [link].

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The Pharma Data

JANUARY 19, 2021

19, 2021 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. NASDAQ: REGN) today announced that it will report its fourth quarter and full year 2020 financial and operating results on Friday, February 5, 2021 , before the U.S. TARRYTOWN, N.Y. , financial markets open.

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The Pharma Data

MARCH 11, 2021

Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. Session Date and Time: Sunday, April 11, 2021 2:00 PM – 3:45 PM ET.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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The Pharma Data

AUGUST 1, 2021

to $6.14; Raises 2021 Adjusted Diluted EPS Guidance Range from $12.37 Based upon the momentum of our business, we are raising our full year 2021 EPS guidance and believe AbbVie is very well positioned for the long term.” ” Second-Quarter Results. Worldwide net revenues were $13.959 billion, an increase of 33.9

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The Pharma Data

APRIL 7, 2021

today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. . Key AbbVie abstracts and presentation details for the 2021 AAN Annual Meeting program are outlined below. Abstract Title. Presentation Details.

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The Pharma Data

JUNE 7, 2022

New Indication for Amgen’s Fifth FDA-approved Biosimilar. Now Approved to Treat All Available Rituxan ® Indications. In 2021, Amgen was named one of the 25 World’s Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron’s.

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The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. By the end of the first quarter of 2021, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S.,

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The Pharma Data

JANUARY 18, 2021

Though the FDA approved a total of 53 novel drugs in 2020, only three of those were considered ahead of time by an advisory committee. Of the nine total approvals that followed positive recommendations by the expert panels, six were for supplemental indications.

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The Pharma Data

APRIL 8, 2021

today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. Abstract Title. Presentation Number (type), Session Title. Presentation Date. risdiplam).

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The Pharma Data

JULY 8, 2021

Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021. The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials. Please see the full Prescribing Information. INDICATION.

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The Pharma Data

JANUARY 7, 2021

8, 2021 11:05 UTC. NASDAQ: AUPH / TSX: AUP) (the “Company”) today announced that members of the management team will participate in two upcoming virtual investor conferences and participate in a panel discussion hosted by Dr. Scott Gottlieb, former FDA Commissioner: H.C. Wainwright Virtual BioConnect 2021 Conference.

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The Pharma Data

MAY 31, 2022

In 2021, Evrysdi was awarded Drug Discovery of the Year by the British Pharmacological Society as well as the Society for Medicines Research award for Drug Discovery. Evrysdi is currently approved in 81 countries and the dossier is under review in a further 27 countries. Food and Drug Administration in 2017.

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The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. .” HELLERUP, Denmark , Jan.

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The Pharma Data

MAY 7, 2021

The information contained in this release is as of May 7, 2021. For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC’s website at www.sec.gov. Pfizer Disclosure Notice.

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The Pharma Data

SEPTEMBER 8, 2021

Adds Rezurock™ (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. Sanofi has entered into a definitive merger agreement with Kadmon Holdings, Inc.

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The Pharma Data

JULY 21, 2021

– Allergan, an AbbVie (NYSE: ABBV) company, today announced that it will present new data from its leading portfolio of eye care medicines at the 2021 ASCRS (American Society for Cataract and Refractive Surgery) Annual Meeting being held July 23-27 in Las Vegas, NV. Robinson , M.D., Linked to ASCRS program. .

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The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. was approved by the European Commission in February 2021. About LIBRETTO-001.

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New Drug Approvals

SEPTEMBER 6, 2024

2 , 3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations. 1 It was approved by the FDA on August 19, 2024. 1 It was approved by the FDA on August 19, 2024. 20 August 2024. 20 August 2024.

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The Pharma Data

NOVEMBER 2, 2020

Food and Drug Administration, Gover said he believes there is a “clear path” to the submission of a New Drug Application as soon as 2021. If nabiximols is approved, this would mark the second cannabis-based product for GW Pharmaceuticals in the United States. Now is the ideal time to develop nabiximols in the U.S.

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The Pharma Data

MAY 17, 2021

Posted 17 May 2021 | By Jeff Craven . The proposed new authority over label changes also would help in situations where a drug has been found to work as well at a dose lower than the FDA-approved dose. © 2021 Regulatory Affairs Professionals Society. JAMA Intern Med Gyawali et al. JAMA Intern Med Gunter et al. .

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The Pharma Data

DECEMBER 16, 2020

Morgan Healthcare Conference on Monday, January 11, 2021. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

APRIL 28, 2023

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults Teva Pharmaceuticals, a U.S. This study was completed in December 2021; results align with the findings of the RISE study.

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Eye on FDA

DECEMBER 6, 2023

For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. Secondly, the meeting outcomes were much more positive than they were in those same years.

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The Pharma Data

JANUARY 6, 2021

Process development and quality control will begin in 2021, and full manufacturing capabilities at the 88,000-square-foot facility will be available in 2023. In addition to its lead program, which began Phase I testing in 2020, the company expects to nominate three clinical candidates in 2021. Oncorus’ stock opened at $32.45

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The Pharma Data

NOVEMBER 15, 2020

In a deal set to be finalized early in 2021, Urovant Sciences has agreed to be fully acquired by largest investor and close partner, Sumitovant Biopharma. Vibegron also showed favorable longer-term efficacy, safety, and tolerability in a 40-week extension study. .

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The Pharma Data

JUNE 2, 2022

BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.

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New Drug Approvals

SEPTEMBER 10, 2024

2] Vorasidenib was approved for medical use in the United States in August 2024. [2] 2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2]

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. FDA-2020-E-1840 (July 13, 2020). These determinations were finalized in 2021.

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The Pharma Data

JANUARY 25, 2021

26, 2021 13:00 UTC. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for VLX-1005 for the treatment of heparin induced thrombocytopenia (HIT). FREDERICK, Md.–( About VLX-1005.

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Advarra

JULY 27, 2022

The document also captures how a product will be managed during the commercial phase of the lifecycle, including relevant post-approval CMC commitments and PACMPs. If your go-to-market strategy requires FDA approval, it may also require a prior approval supplement. Go-to-market Strategy.

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