pharmaphorum

MARCH 16, 2021

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. Early commercial batches of Pfizer/BioNTech’s COVID-19 vaccine had lower than expected levels of intact mRNA.

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Bio Pharma Dive

APRIL 7, 2021

Europe's drug regulator affirmed the benefits of vaccination outweigh the risks, but recommended the shot's label be updated to warn of the newly established side effect.

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Vaccination Vaccine Regulation Drugs 246

Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Vaccines predicated on neoantigens therefore elicit truly tumour-specific T cell responses.

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Regulation Vaccination Vaccine Trials 52

pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 11, 2023

The Central Drugs Standard Control Organisation (CDSCO) has declared a batch of Typbar, the typhoid polysaccharide vaccine from Bharat Biotech International Ltd as not of standard quality (NSQ).

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AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 22, 2022

Indian drug regulators have sought pharmacovigilance (PV) for neuropathic pain drugs gabapentin and pregabalin due to cardiovascular related adverse event citing a study by American medical journal Cardiovascular Diabetology.

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Bio Pharma Dive

MARCH 18, 2021

The two drug regulators each believe the benefits of the shot outweigh the risks after investigating rare and unusual clotting events that have led more than 20 countries to halt vaccinations.

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Vaccination Vaccine Regulation Drugs 198

NY Times

APRIL 20, 2021

The European Union’s drug regulator said that the Johnson and Johnson vaccine should carry a warning of potential risk for rare blood clots on the label, but did not recommend stopping the vaccine, saying the benefits of the vaccine outweighed the risks.

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Regulation Vaccination Vaccine Drugs 53

Bio Pharma Dive

JUNE 29, 2022

Between July and September, the regulator could approve a first-of-its-kind autoimmune drug and two gene therapies as well as decide how COVID-19 vaccines should be updated.

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Bio Pharma Dive

AUGUST 15, 2022

Britain’s drug regulator is the first public health authority to clear a vaccine designed to fight omicron as well as the original strain of the virus.

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Regulation Vaccination Vaccine Drugs 246

Bio Pharma Dive

OCTOBER 1, 2021

Regulators face key decisions on COVID-19 shots for children and boosters for Moderna's and J&J's vaccines. Other closely watched drugs for multiple myeloma and depression are under review, too.

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XTalks

APRIL 15, 2021

Federal authorities in the US have recommended pausing the administration of J&J’s COVID-19 vaccine as half a dozen cases of rare blood clots reported among women who received the vaccine are under investigation. Related: COVID-19 Vaccine Messaging: Why Vaccine Efficacies Can’t Be Compared and Shopped.

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Vaccination Vaccine Regulation Drugs 98

Pharmaceutical Technology

JUNE 24, 2022

As regulatory agencies gear up for another round of Covid-19 vaccine deliberations centered on emerging variants, Moderna has released data on its booster’s efficacy against Omicron subvariants. The mRNA-1273.214 booster contains the original Spikevax vaccine and a candidate targeting Omicron BA.1 1 variant of concern.

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Pharmaceutical Technology

APRIL 11, 2023

The US Food and Drug Administration (FDA) has granted final approval to India-based Zydus Lifesciences ‘ 500mg azithromycin tablets for the treatment of bacterial infections. Zydus will manufacture the drug at its formulation facility in Moraiya, Ahmedabad, in the Indian state of Gujarat.

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XTalks

NOVEMBER 9, 2020

SARS-CoV-2 Vaccines Inch Towards Regulatory Approval. Over the past month or so, investigators have been amassing data on SARS-CoV-2 candidate vaccines as quickly as possible and some of that data is making its way—ever so much more slowly—through regulatory agencies for official scrutiny.

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World of DTC Marketing

FEBRUARY 28, 2021

SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. Can a COVID-19 vaccine approval suddenly erase that? billion in penalties.

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NY Times

AUGUST 20, 2021

Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and possibly kicking off a wave of new mandates.

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Vaccination Vaccine Licensing Licensing 145

World of DTC Marketing

SEPTEMBER 7, 2021

Politico reported Thursday that in recent private discussions with lawmakers, pharmaceutical lobbyists have explicitly invoked the industry’s role in the rapid development of coronavirus vaccines as an argument against proposed fixes for out-of-control prescription drug costs and other regulations.

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Drug Discovery World

MARCH 17, 2023

The drug has been accepted for the treatment of chronic HDV infection in adult patients with evidence of significant fibrosis, whose disease has responded inadequately to interferon-based therapy or who are ineligible to receive interferon-based therapy due to intolerance or contra-indication.

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Regulation Drugs Licensing Licensing 52

pharmaphorum

NOVEMBER 2, 2020

The UK drugs regulator has awarded a £1.5 million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).”.

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Vaccination Vaccine Regulation Trials 145

pharmaphorum

JANUARY 7, 2021

The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. As things stand, the two rival mRNA-based vaccines from Pfizer/BioNTech and Moderna are now approved for use in the EU.

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Vaccination Vaccine Regulation Medicine 141

Pharmaceutical Technology

APRIL 12, 2023

Taiwan Shionogi, a subsidiary of the Japanese pharmaceutical company Shionogi, has filed an application with the Taiwan Food and Drug Administration (TFDA) to obtain emergency use authorisation (EUA) for ensitrelvir fumaric acid (ensitrelvir). Phase IIb/III of the Phase II/III trial is currently being conducted in Asia, chiefly in Japan.

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Drugs Trials Regulation Vaccination 147

XTalks

MAY 28, 2024

In a move signaling a major shift in influenza prevention strategies, CSL Seqirus, a global leader in flu vaccines, has transitioned from quadrivalent to trivalent formulations for the upcoming 2024/25 flu season in the US.

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Rethinking Clinical Trials

FEBRUARY 7, 2024

Food and Drug Administration, FDA, Misinformation, Communication, Health Information Key Points U.S. – Were you able to examine responses from groups that can be particularly challenging such as vaccine deniers and climate change skeptics?             Speaker Susan C.

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Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Continued authorization for COVID-19 drugs.

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Regulation Drugs Vaccination Vaccine 52

pharmaphorum

OCTOBER 28, 2022

The EMA has delivered some good news to GSK on a new long-acting HIV drug and vaccine for respiratory syncytial virus (RSV), in a week that saw multiple disappointments in other R&D projects. Those developments have placed much more onus on other projects – and particularly GSK’s RSV vaccine – to deliver quickly.

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Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Iomab-B met the durable complete remission endpoint.

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The Pharma Data

AUGUST 17, 2020

The Chinese Centre for Drug Evaluation (CCDE) has said that coronavirus vaccines must show 50 percent efficacy to be approved. . The CCDE also said companies would have to prove their vaccines could provide immunity from the virus for a minimum of six months and be effective for 70 percent of the population. . Conor Kavanagh.

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Vaccination Vaccine Regulation Drugs 52

XTalks

NOVEMBER 23, 2021

Canadian pharma and biotech contract development and manufacturing organization (CDMO) Biovectra has announced plans for building one of the first state-of-the-art mRNA vaccine and biomanufacturing facilities in Canada. Related: Medicago’s Plant-Based COVID-19 Vaccine Enters Human Trials. million, respectively.

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pharmaphorum

DECEMBER 24, 2020

The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days. Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.

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Vaccination Vaccine Regulation Life Science 126

Drug Discovery World

FEBRUARY 12, 2024

million grant to engineer microbial cell factories to produce membrane proteins which will support future drug screening and sustainable chemical production. The top ten selling medicines worldwide and multiple vaccines, including those for Covid-19, hepatitis B and whooping cough, target membrane proteins.

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Research Drugs Protein Engineer 105

NY Times

JULY 12, 2021

Federal regulators concluded that the risk of developing the syndrome was low, and that the benefits of the vaccine still strongly outweigh it.

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Vaccination Vaccine Regulation Development 116

NY Times

MAY 28, 2021

The United States began vaccinating children in that age group earlier this month.

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Vaccination Vaccine Regulation Drugs 94

Drug Discovery World

AUGUST 3, 2023

It becomes the ninth Covid-19 vaccine to be authorised by the UK’s independent medicines regulator. The vaccine demonstrated a strong immune response, and the most common side effects were mild, and self-resolved within a few days of vaccination. It is approved as a booster injection for those aged 16 years and over.

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STAT News

JANUARY 19, 2023

Food and Drug Administration and the U.S. In their own statement, the companies acknowledged that they were aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated booster. Last Friday, the U.S. Continue to STAT+ to read the full story…

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Clinical Trials Clinical Trials Regulation Drugs 97

BioPharma Reporter

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted Pfizerâs Biologics License Application (BLA) for its maternal RSV vaccine under priority review. If approved, the vaccine will become the first RSV vaccine for pregnant women to protect against RSV in infants.

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BioPharma Reporter

NOVEMBER 3, 2022

The US Food and Drug Administration (FDA) has granted Priority Review to GSKâs respiratory syncytial virus (RSV) older adult vaccine candidate with a decision expected in May 2023: which could make it the first vaccine approved against the virus.

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