The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.

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The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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The Pharma Data

DECEMBER 11, 2020

FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. Government to supply doses in 2020 & 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. immediately.

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Drug Discovery World

MAY 6, 2024

Europe is traditionally a life sciences powerhouse, with a strong tradition in pharmaceutical discovery. The oldest, still active pharmaceutical company worldwide, Merck, started life in 1668 in Darmstadt, Germany. Members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) spent €41.5

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The Pharma Data

MAY 6, 2021

Under the MoU, the companies and the IOC will coordinate with National Olympic Committees (NOCs) around the world to understand and work to help address the local need for vaccine doses for national delegations’ participation in the Games. We are proud to play a role in providing vaccines to athletes and national Olympic delegations.”.

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The Pharma Data

DECEMBER 9, 2020

With the expected Emergency Use Authorization (EUA) of Pfizer – BioNTech and Moderna ’s COVID-19 vaccines providing hope that the COVID-19 pandemic will soon be resolved, 2021 is going to need a new primary healthcare campaign. Atlas cofounded, seeded and incubated Vigil, with pre-clinical stage assets in-licensed from Amgen Inc.,

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The Pharma Data

JANUARY 9, 2021

Expects continued strong financial and operating momentum in 2021, forecasting total revenues of $2 billion at the midpoint and Adjusted EBITDA of $780 million at the midpoint, both increases year-over-year. 10, 2021 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. . 2021 FINANCIAL FORECAST. .

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The Pharma Data

JANUARY 13, 2021

GMP Production of TNX-1500 is Expected to be Available in the Third Quarter of 2021. 14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. WO 2021/001458 A1. Tonix Pharmaceuticals Holding Corp. CHATHAM, N.J., Holding Corp. 1 Lederman, S. 175:1091-1101 (1992) 2 Karpusas, M et al., Structure.

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The Pharma Data

MAY 6, 2021

Another set of proposals is intended to support “a competitive and innovative EU pharmaceutical industry.” The rolling review idea is based on the experience of authorizing COVID-19 vaccines. . © 2021 Regulatory Affairs Professionals Society. The report also addresses bolstering the resilience of supply chains. EMA Report. .

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The Pharma Data

NOVEMBER 20, 2020

billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization. BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date. by the middle to end of December 2020. participants are 56-85 years of age.

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The Pharma Data

JANUARY 18, 2021

18, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 2:30 PM ET. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 2:30 PM ET. SEMDEXA is a trademark of Semnur Pharmaceuticals, Inc.

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The Pharma Data

SEPTEMBER 9, 2020

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. billion doses by the end of 2021. billion doses by the end of 2021. CEO and Co-founder of BioNTech.

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The Pharma Data

APRIL 27, 2021

All doses expected to be delivered in 2021. NEW YORK and MAINZ, GERMANY, April 19, 2021 (GLOBE NEWSWIRE) — Pfizer Inc. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021.

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The Pharma Data

AUGUST 20, 2020

times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 billion doses by the end of 2021. study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. Jansen, Ph.D.,

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The Pharma Data

DECEMBER 1, 2020

has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. The distribution of the vaccine in the U.K. View the full release here: [link].

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The Pharma Data

OCTOBER 26, 2020

Testing Therapies, Antivirals and Vaccines. Novavax will present data from an ongoing Phase I/II clinical trial, including new Phase II reactogenicity data from its COVID-19 vaccine candidate. Food and Drug Administration greenlit the restart of AstraZeneca’s Phase III COVID-19 vaccine trial, the U.K.-based

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Drug Discovery World

APRIL 20, 2023

Symptoms affect the brain, heart, lungs, GI tract and pancreas, are seen equally in vaccinated populations, and sometimes newly emerge after the acute infection has resolved. Is it time for the pharmaceutical industry to join in? 2021, doi: 10.1038/ s41598-021-92045-x. 2021, doi: 10.1016/j.eclinm.2021.101019. 26, 2022).

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The Pharma Data

DECEMBER 10, 2020

. Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose. Jansen, Ph.D.,

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The Pharma Data

NOVEMBER 9, 2020

Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announces new initiatives to help COVID-19 patients in India as part of its commitment to bring the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. VACCINATIONS: Avoid use of live vaccines with Olumiant.

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The Pharma Data

OCTOBER 25, 2020

Army Medical Research and Development (USAMRDC ) initiated a Phase I clinical trial of its novel vaccine against COVID-19. The vaccine candidate is called “spike ferritin nanoparticle” (SpFN) and uses ferritin—“attaching a certain type of spike protein to a polymerized version of ferritin,” according to the organization.

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Drug Channels

OCTOBER 19, 2020

Get ready to hit the ground running in 2021 by closing out the year at Trade and Channel 2020 ! 16th Annual Life Sciences Trade and Channel Strategies. December 1-3, 2020 | Virtual Event www.informaconnect.com/trade-channel. Download the agenda to plan your sessions and wrap up your week armed with critical updates and valuable takeaways.

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Drug Discovery World

SEPTEMBER 6, 2022

Unsurprisingly, oncology remains the biggest focus for cell and gene therapy developers, accounting for 52% of clinical activity in 2021, according to ARM’s Regenerative Medicine: Disrupting the Status Quo report. Cancer is king . Manufacturing . New indications .

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The Pharma Data

OCTOBER 26, 2021

We believe that molnupiravir will be an important addition to the range of public health tools to fight COVID-19 – including the vaccines developed by the exploration- grounded pharmaceutical assiduity, which remain essential and are the first- line of defense against this epidemic.”. “ million courses of molnupiravir to theU.S.

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Agency IQ

FEBRUARY 15, 2024

Modeled after a similar pathway for pharmaceuticals – the Innovative Licensing Access Pathway (ILAP) – the new pilot program intends to ensure end-to-end assistance for developers of innovative devices addressing unmet medical needs. cancer vaccines, cardiovascular disease). Read AgencyIQ’s complete analysis of the program here.

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Agency IQ

JANUARY 19, 2024

This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021. The rate of negative opinions over the last three years has remained relatively stable, with three each in 2023 and 2022 and five in 2021. The EMA has now seen a three-year decline in new active substances, with 54 in 2021, 44 in 2022 and 39 in 2023.

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The Pharma Data

JANUARY 15, 2021

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. and Genmab A/S entered into a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. link] Accessed January 2021. [3] 2] Mayo Clinic.

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The Pharma Data

OCTOBER 26, 2020

Demand for our products remains robust, and production, supply and distribution of our medicines, vaccines and animal health products are moving forward with minimal disruption,” said Kenneth C. billion related to certain license and collaboration agreements, and certain other items. Non-GAAP EPS of $1.74 COVID-19 Research Highlights.

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The Pharma Data

MARCH 4, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) and Ovid Therapeutics Inc. The new agreement is expected to close by end of March 2021, subject to the satisfaction of customary closing conditions, including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act. “I

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The Pharma Data

FEBRUARY 12, 2022

“As a global pharmaceutical company, Lilly has worked hard to fight this pandemic. Lilly has licensed and developed bebtelovimab after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. About BLAZE-4.

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The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process. About Roche.

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The Pharma Data

APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% at CER driven by growth drivers Dupixent ® and Vaccines. Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere. Sanofi continued its growth trajectory.

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The Pharma Data

DECEMBER 9, 2020

A solution could be at hand with Overland Pharmaceuticals. HALIX – Based in The Netherlands, HALIX BV and AstraZeneca forged an agreement to support large-scale commercial drug substance manufacture of AZD1222, the adenovirus vector-based COVID-19 vaccine. Amolyt Pharma – France-based Amolyt Pharma and PeptiDream, Inc.

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. Ricks , Lilly chairman and CEO.

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Drug Discovery World

FEBRUARY 20, 2023

Breast cancer In April, Biotech ISA Pharmaceuticals launched a clinical trial using its Amplivant adjuvant technology to test Scancell’s Modi-1 vaccine in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer. The candidate demonstrated 64.7%

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The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.

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Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. That means we could see an updated agenda in late June or early July, giving us a better sense of what FDA is working on and when it hopes to complete its rulemaking. The following PDUFA dates were obtained from publicly available sources.

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