Codon

NOVEMBER 1, 2024

Although Amodei does acknowledge some real-world issues limiting scientific progress — such as the slow growth of organisms and tedious clinical trials — he mostly passes over the more general tools that will be required to accelerate research in the near term. This essay focuses on how we might do both, specifically for the cell.

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BioPharma Drive: Drug Pricing

JULY 10, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Moderna COVID vaccine gets full approval for children The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., Kennedy Jr.

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BioPharma Drive: Drug Pricing

JULY 10, 2025

Spencer Platt via Getty Images The first marketed treatment for the insatiable hunger associated with Prader-Willi disease is selling more quickly than Wall Street analysts expected, an early, but encouraging sign of demand. You can unsubscribe at anytime. Condulis, for instance, predicts Vykat could reach $2.5

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Drug Target Review

MAY 5, 2025

We have seen how quickly vaccines and treatments can be developed when innovation is prioritised and stakeholders work together against the backdrop of imminent societal needs. The staggering average cost of bringing a drug to market (more than $1 billion) is accompanied by a dismal success rate of justfive to seven percent.

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BioPharma Drive: Drug Pricing

JULY 2, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Organon drug for endometriosis falls short in mid-stage study Company executives had seen the drug as a potential multi-billion dollar opportunity in women’s health.

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

and sold [Karuna],” wrote RBC Capital Markets analyst Brian Abrahams, in a note to clients. Incyte expects multiple pivotal trial readouts this year, along with proof-of-concept data for several pipeline candidates. says US won’t donate to global vaccine effort View all Events 07 JUL Webinar | 10 a.m.

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BioPharma Drive: Drug Pricing

JUNE 27, 2025

Dive Insight: Since the FDA’s approval of Novartis’ Kymriah for leukemia in 2017, six more CAR-T therapies have reached market. cell therapy market,” Daina Graybosch, an analyst at Leerink Partners, wrote in note to clients. You can unsubscribe at anytime.

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Codon

JULY 14, 2025

However, in a Bayer management meeting to discuss whether acetylsalicylic acid should go forward to clinical trials, Dreser asserted that it was a direct cardiac poison and opposed it progressing to trials. Dreser had the right to veto any drug going to clinical trials, so this is where the story of aspirin could have ended.

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FDA Law Blog: Biosimilars

MAY 15, 2025

Dr. Makary noted that he doesnt believe that the traditional playbook works for everythingparticularly in the case of life-threatening diseases where randomized controlled trials are neither feasible nor humane.

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BioPharma Drive: Drug Pricing

JULY 22, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief // Vaccines Sanofi to acquire vaccine biotech in billion-dollar deal The French pharma will pay $1.15 VXB-241 is currently in Phase 1 testing.

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The Pharma Data

AUGUST 7, 2020

AstraZeneca has signed its first deal in China to produce and deliver its vaccine candidate against COVID-19 in the country, partnering up with manufacturing firm Shenzhen Kangtai Biological Products. billion citizens in China, and the country is AstraZeneca’s biggest market. There are around 1.4

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The Pharma Data

OCTOBER 22, 2020

COVID-19 Vaccine Trial Enrolls 30,000. 22, 2020 — The first company to start a phase 3 trial of a COVID-19 vaccine reached its target of enrolling 30,000 participants, CNN reported Thursday. Half of the participants were given the vaccine and half received a placebo. trial in August. Professional.

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The Pharma Data

SEPTEMBER 14, 2020

After sparking a wave of concern through industry and mainstream media with the news it had halted international studies investigating its COVID-19 vaccine on 6 September, AstraZeneca has now announced that clinical trial operations conducted alongside its partners at the University of Oxford are now back in full swing. Matt Fellows.

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The Pharma Data

AUGUST 12, 2020

Mexico aims to conduct late stage trials for coronavirus vaccines designed by US and Chinese companies. This is in hope that these countries may base their vaccine production in Mexico. Ebrard said he hoped that trials would start between next month and January if they get approval from Mexico’s food and drug agency.

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The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

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The Pharma Data

MARCH 18, 2021

Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to announce the start of Phase 3 clinical testing of Medicago’s plant-derived COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, as part of the ongoing Phase 2/3 study. g of CoVLP are administered 21 days apart.

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PPD

JUNE 13, 2023

Clinical trials for COVID-19 vaccines changed how all vaccine trials are conducted. The success of the COVID-19 vaccines has brought renewed interest to vaccine development across indications and therapeutic areas. Working with a vertically integrated organization can further accelerate market entry.

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The Pharma Data

OCTOBER 26, 2021

Pfizer and BioNTech SE blazoned topline results from a Phase 3 randomized, controlled trial assessing the efficacity and safety of a 30-µg supporter cure of the Pfizer-BioNTech COVID-19 Vaccine in further than individualities 16 times of age and aged. The observed relative vaccine efficacity of95.6 (95 95 CI89.3,98.6)

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The Pharma Data

JUNE 24, 2021

The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines. Secondary objectives are to describe immune responses produced by each of the vaccines.

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The Pharma Data

MAY 4, 2021

The European Medicines Agency (EMA) has added Sinovac’s COVID-19 vaccine to its portfolio of vaccines under rolling review. . CureVac’s CVnCoV COVID-19 vaccine and NVX-CoV2372, the Novavax candidate, have been under review since February 2021. Posted 04 May 2021 | By Kari Oakes .

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The Pharma Data

NOVEMBER 22, 2021

Pfizer-BioNTech vaccine demonstrated 100 efficacity against COVID-19 in longer- term analysis, with no serious safety enterprises linked. Data will support planned cessions for full nonsupervisory blessing of the vaccine in this age group in theU.S. and worldwide NEW YORK & MAINZ, Germany– (BUSINESS WIRE)– PfizerInc.

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The Pharma Data

DECEMBER 23, 2020

company developing UB-612 a multitope peptide-based vaccine to fight COVID-19, today announced an exclusive agreement with Aurobindo Pharma to expand its global development and commercialization of UB-612 to India and the United Nations Children’s Fund (UNICEF) agency. billion, to deliver the vaccine in multiple countries.

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

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The Pharma Data

JUNE 24, 2021

today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY ® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group.

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The Pharma Data

NOVEMBER 23, 2020

As the Pfizer-BioNTech COVID-19 vaccine is being evaluated by the U.S. Food and Drug Administration (FDA) and the Moderna vaccine is soon to follow, here’s a look at several of the top COVID-19 vaccine candidates and where they stand as of today. The prices for the vaccines are moving targets, dependent upon the amount ordered.

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The Pharma Data

MAY 3, 2021

The European Medicines Agency (EMA) is evaluating an application submitted by Pfizer and BioNTech for use of their COVID-19 vaccine in children aged 12 to 15 years. . The vaccine has been authorized by the EU for use in people 16 years and up since December 2020. . Pfizer also shared antibody responses from the younger age group.

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The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. Trials are also being run in the U.S.,

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The Pharma Data

DECEMBER 30, 2020

30 December 2020 — AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. It has been shown to be effective, well-tolerated, simple to administer and is supplied by AstraZeneca at no profit.

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The Pharma Data

OCTOBER 15, 2020

Moderna is working with international regulators to accelerate approval of the company’s coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, which is currently leading the global COVID-19 vaccine race alongside vaccine candidates from AstraZeneca, Pfizer and Johnson & Johnson. The Cambridge, Mass.-based

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The Pharma Data

JANUARY 11, 2021

Two Billion COVID-19 Vaccine Doses From BioNTech Expected This Year. 11, 2021 — A boost in manufacturing should enable Germany’s BioNTech to produce 2 billion doses of its COVID-19 vaccine this year, the company says. BioNTech and partner Pfizer developed the first COVID-19 vaccination to be brought to market.

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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

DECEMBER 14, 2020

ICU nurse Sandra Lindsay, with Long Island Jewish Medical Center in Queens, New York, received the Pfizer-BioNTech COVID-19 vaccine. Food and Drug Administration (FDA) ’ s Vaccines and Related Biological Products Advisory Committee on Thursday, December 17. Both vaccines have demonstrated about 94-95% efficacy in clinical trials.

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The Pharma Data

JANUARY 6, 2021

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union.

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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. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021.

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The Pharma Data

AUGUST 6, 2020

We pointed out last week that China was a notable missing element in AstraZeneca’s COVID-19 vaccine strategy, despite being the drugmaker’s second-largest market. The pair will also explore the possibility of producing the vaccine for other markets. The country is its second-largest market, behind the U.S.,

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The Pharma Data

AUGUST 10, 2020

Novavax is partnering up with the Serum Institute of India Private Limited (SIIPL) in a licensing deal to development and marketing of up to one billion doses of its potential recombinant COVID-19 vaccine candidate, NVX?CoV2373. Negotiations are currently ongoing to have SIIPL manufacture the candidate within India. M adjuvant.

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