The Pharma Data

JANUARY 17, 2021

FDA also designated LAPS Triple Agonist (HM15211) as an orphan drug for the treatment of primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC) in 2020, and the indications will be expanded to include idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD) as well.

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The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 37% of trial volunteers are from racial and ethnic minorities.

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The Pharma Data

NOVEMBER 20, 2020

November 20, 2020 — The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. Source: FDA. Posted: November 2020.

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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. This is the first authorisation for this vaccine.

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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

NOVEMBER 9, 2020

09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate.

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The Pharma Data

DECEMBER 11, 2020

11, 2020 – The U.S. Food and Drug Administration is expected to approve emergency use of Pfizer’s coronavirus vaccine as early as Saturday after its advisory panel cleared the way for the start of a national campaign to inoculate Americans and stem the spread of COVID-19. FRIDAY, Dec. Initially, a shipment of 2.9

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The Pharma Data

NOVEMBER 30, 2020

30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. Novavax will use vaccine material produced at commercial scale for this trial. GAITHERSBURG, Md.,

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. That requirement would only be fulfilled if FDA agreed to such a change. But we digress. And indeed, after Pliva v.

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The Pharma Data

DECEMBER 10, 2020

10, 2020 – A U.S. Food and Drug Administration advisory panel will vote on Thursday whether to recommend emergency approval of Pfizer’s coronavirus vaccine, a decision that will come not a moment too soon as the country reported more than 3,000 new COVID-19 deaths on Wednesday. THURSDAY, Dec. Meanwhile, U.S.

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The Pharma Data

NOVEMBER 23, 2020

23 November 2020 . Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. .

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The Pharma Data

AUGUST 14, 2020

In other news, Genentech’s Evrysdi (risdiplam) has secured FDA approval for the treatment of spinal muscular atrophy and Bristol Myers Squibb has announced positive data from two Phase 3 clinical trials of its drug Opdivo. AstraZeneca seals manufacturing deal to deliver COVID-19 vaccine in China.

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The Pharma Data

JANUARY 6, 2021

6 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials.

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The Pharma Data

SEPTEMBER 15, 2020

Next-generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly 100 percent preventable with proper screening, vaccination and treatment. Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Carcinogenic human papillomavirus infection.

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The Pharma Data

DECEMBER 30, 2020

The year 2020 will certainly go down in history as the year of COVID-19. Gilead Sciences Makes Multiple Bets : When Gilead Sciences wasn’t working on remdesivir in COVID-19, the company seemed to be constantly flexing its M&A muscle over the course of 2020. It began in May with the $4.9 But the U.K.-based

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The Pharma Data

DECEMBER 18, 2020

18, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SILVER SPRING, Md. , Hahn , M.D.

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The Pharma Data

DECEMBER 10, 2020

11, 2020 02:48 UTC. –( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. CULVER CITY, Calif.–(

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The Pharma Data

NOVEMBER 16, 2020

16, 2020– Moderna, Inc. We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. Room Temperature for Vaccination: Once the vaccine is removed from the refrigerator for administration, it can be kept at room temperature conditions for up to 12 hours. CAMBRIDGE, Mass.–(BUSINESS

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The Pharma Data

JANUARY 12, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland. million doses of the COVID-19 Vaccine Moderna. About the COVID-19 Vaccine Moderna.

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The Pharma Data

DECEMBER 3, 2020

4, 2020 08:00 UTC. The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.

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The Pharma Data

JUNE 6, 2022

Priorix becomes an additional source of measles, mumps and rubella vaccine for US patients. 4] The report also noted 400,000 fewer children entered kindergarten in the 2020-2021 school year than expected nationally, meaning those children may not be up to date on childhood immunisations like their MMR vaccination. [4].

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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 billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization. by the middle to end of December 2020. participants are 56-85 years of age.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Janssen Biotech, Inc.

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The Pharma Data

DECEMBER 11, 2020

Friday, 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.

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The Pharma Data

DECEMBER 13, 2020

14, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration (FDA) approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. The FDA, an agency within the U.S. .

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The Pharma Data

FEBRUARY 1, 2021

This approval expands Biogen’s industry-leading portfolio of MS treatments, which also includes the subcutaneous (SC) administration of Plegridy, and follows the European Commission’s marketing authorization for the IM administration in December 2020. “At MS, the coronavirus and vaccines – updated global advice. Source link.

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The Pharma Data

DECEMBER 10, 2020

Thursday, 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.

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The Pharma Data

NOVEMBER 16, 2020

16, 2020– Moderna, Inc. The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. .–(BUSINESS WIRE)–Nov.

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The Pharma Data

NOVEMBER 30, 2020

30, 2020– Moderna, Inc. The data analysis indicates a vaccine efficacy of 94.1%. The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Nov.

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Codon

AUGUST 26, 2024

He also explains how they could be used to combat pandemics on “day zero,” well before vaccines are developed. After the outbreak ended, it took another three years for the first Ebola vaccine by Merck to be approved. Timelines for vaccine development are shrinking, but can it move even faster?

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JANUARY 9, 2021

Reports preliminary 2020 total revenues of $1.55 billion at the midpoint and Adjusted EBITDA of $635 million at the midpoint, both at or above prior guidance given in November 2020. NYSE:EBS) today announced its financial forecast for 2021 and selected preliminary unaudited financial results for 2020.

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EG Life Sciences

FEBRUARY 15, 2023

The US Food and Drug Administration (FDA) approved around 26 novel drugs in 2022. Approval processes were slow in comparison to 2020 and 2021, where 53 and 50 approvals were achieved respectively. Going into the third year of the pandemic, we know that the virus still impacts industry operations.

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The Pharma Data

DECEMBER 8, 2020

8, 2020– Moderna, Inc., Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 8, 2020– Moderna, Inc.,

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The Pharma Data

NOVEMBER 18, 2021

Worldwide, it’s estimated there were further than new cases of order cancer diagnosed and further than deaths from the complaint in 2020. Utmost cases of RCC are discovered apropos during imaging tests for other abdominal conditions. In theU.S., About Merck’s Beforehand-Stage Cancer Clinical Program. About Merck.

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NOVEMBER 9, 2020

NEW YORK & MAINZ, GERMANY–(BUSINESS WIRE) 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. Pfizer Inc. Today is a great day for science and humanity.

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JULY 29, 2021

It is approved for paediatric use in SEA from ages six to 17 in Europe, the US and several other markets. In the US, Japan, Canada and a number of other markets, it is approved for use in adult patients with EGPA. It is not currently approved for use in COPD anywhere in the world. Consider vaccination if medically appropriate.

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The Pharma Data

OCTOBER 29, 2020

Data support baricitinib’s ongoing Phase 3 program and potential to be the first approved medicine for people living with alopecia areata (AA). . VACCINATIONS : Avoid use of live vaccines with Olumiant. 1 Olumiant Prescribing Information, 2020. INDIANAPOLIS , Oct. 2 Walker JG and Smith MD. J Rheumatol.

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