The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Novartis today announced that the U.S. SVP, Chief Medical Officer, Novartis Gene Therapies.

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The Pharma Data

OCTOBER 30, 2020

If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. Department of Health and Human Services under OT number: HHSO100201700020C. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021.

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Production Antibody Manufacturing Trials 52

Druggist

NOVEMBER 17, 2020

When prescribed, PPIs, including esomeprazole and omeprazole, have a wider licensed used. Note: Nexium Control, which is available over the counter contains 20mg of esomeprazole, which is equivalent to prescription-only esomeprazole 20mg. . pylori), management of ‘ reflux ‘ symptoms. . £11.99. −£1.99.

Drugs 87

Drugs Production Branding Medicine 87

The Pharma Data

OCTOBER 28, 2020

Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 Based on this finding, Regeneron is reviewing potential changes to dosing in the ongoing outpatient clinical trial given the current limited supply of REGN-COV2.

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The Pharma Data

DECEMBER 29, 2020

NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. In the U.S.

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Antibody Trials Production Clinical Trials 52

Druggist

NOVEMBER 17, 2020

When prescribed, PPIs, including esomeprazole and omeprazole, have a wider licensed used. Note: Nexium Control, which is available over the counter contains 20mg of esomeprazole, which is equivalent to prescription-only esomeprazole 20mg. . pylori), management of ‘ reflux ‘ symptoms. . £11.99. −£1.99.

Drugs 52

Drugs Production Branding Medicine 52

The Pharma Data

JANUARY 12, 2021

“Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., Disclosure Notice.

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Drugs Licensing Licensing Production 110

The Pharma Data

DECEMBER 17, 2020

Data from the Phase 1/2/3 clinical trial supported an Emergency Use Authorization for casirivimab and imdevimab administered together, granted by the U.S. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. ,

Antibody 52

Antibody Medicine Production Trials 52

Pfizer

DECEMBER 20, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., Disclosure Notice.

Drugs 69

Drugs Licensing Licensing Containment 69

The Pharma Data

DECEMBER 5, 2020

Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. (..)

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Antibody Production Trials Medicine 40

The Pharma Data

JANUARY 9, 2021

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers.

Production 52

Production Manufacturing Vaccination Vaccine 52

Pfizer

NOVEMBER 23, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., Our Commitment to Access. Disclosure Notice.

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Licensing Licensing Drugs Manufacturing 40

The Pharma Data

NOVEMBER 5, 2020

The RECOVERY IDMC is aware of the IDMC recommendations made in connection with the REGN-COV2 treatment trials (described above), and will be discussing the impact, if any, on the RECOVERY trial. R&D: Up-front payments related to license and collaboration agreements. (85). Oncology Program. 50% PD-L1 expression.

Sales 52

Sales Production Manufacturing Antibody 52

The Pharma Data

AUGUST 6, 2020

See “Worldwide Pro Forma Revenue” in Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period. In June, the company and Acceleron Pharma Inc. Regulatory.

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Production Branding Marketing Licensing 52

The Pharma Data

NOVEMBER 20, 2020

We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 3, 2021

The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. Numbers may not add due to rounding.

Antibody 52

Antibody Sales Development Production 52

XTalks

AUGUST 2, 2023

2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. It contains the antiviral medications nirmatrelvir and ritonavir. a month for either 150 mg or 300 mg dose strength packages, and $3,462.13 This partnership will expand the company’s immunology pipeline. billion ($3.65

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Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

NOVEMBER 21, 2020

We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.

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Antibody Production Clinical Trials Clinical Trials 40

The Pharma Data

JANUARY 21, 2021

CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression. Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. Janssen is the marketing authorization holder for EDURANT ® in the U.S.

FDA Approval 52

FDA Approval RNA Drugs Containment 52

The Pharma Data

NOVEMBER 30, 2020

I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. The Company expects that the U.S. government has agreed to provide up to $1.525 billion to purchase supply of mRNA-1273 under U.S.

Vaccination 52

Vaccination Vaccine Medicine Clinical Trials 52

The Pharma Data

OCTOBER 27, 2020

The ongoing NEXT protocol, which is supported and funded by BARDA, enables the continued clinical use of NexoBrid for U.S. patients during the review of the NexoBrid Biologics License Application (BLA). Vericel holds an exclusive license for North American commercial rights to NexoBrid. HHSO100201500035C.

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The Pharma Data

MAY 13, 2021

In a major double-blind clinical trial published in the American College of Endocrinology…. And that contains these ingredients in the same dosages as were used in many of the studies you saw today. And each bottle of HB5 contains a full 30 days supply. So go ahead and choose your discounted package of HB5 right now….

Hormones 52

Hormones Insulin Production Packaging 52

The Pharma Data

OCTOBER 14, 2020

Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. (..)

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FDA Approval Antibody Production Trials 52