Pfizer and Flynn accused of overcharging NHS for anti-epilepsy drugs
Competition regulator the CMA alleges drugs firms abused dominant position with unfairly high prices Pharmaceutical companies Pfizer and Flynn have been accused by the UK’s […]
Competition regulator the CMA alleges drugs firms abused dominant position with unfairly high prices Pharmaceutical companies Pfizer and Flynn have been accused by the UK’s […]
Eli Lilly and Incyte have another rival in the rear-view mirror for Olumiant in alopecia areata after Pfizer reported that its ritlecitinib improved scalp hair […]
The UK government has confirmed that the national COVID-19 vaccination campaign will be extended to include 16 and 17-year-old children, to tackle an increase in […]
Germany’s health ministry has said it will start offering booster COVID-19 vaccines to vulnerable people from next month, amid concerns about rising cases of the […]
The firms are already taking the lion’s share of earnings from the market, as this week’s results will show Praised for preventing hundreds of thousands […]
Not-for-profit pledge sees British firm’s sales revenue fall significantly short of US rival Pfizer Coronavirus – latest updates See all our coronavirus coverage AstraZeneca’s Covid-19 […]
Initially touted as a ‘primary’ vaccine to help immunise Australia by the end of this year, Novavax will now form part of the booster strategy […]
A real-world study carried out in Canada had found that COVID-19 vaccines from AstraZeneca, Pfizer/BioNTech and Moderna reduce the chances of being hospitalised or dying […]
Arvinas’ early clinical data for its targeted protein degradation drug for breast cancer drew partnering interest from several companies. Pfizer beat them all with a […]
Pfizer has pledged a whopping $11 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ […]
The FDA has approved a new pneumococcal vaccine from Merck & Co, just over a month after Pfizer got a green light for a new […]
Already facing one rival to its blockbuster pneumococcal vaccine Prevnar, Pfizer could have another to contend with, after Affinivax reported positive phase 2 results with […]
• Pharma company presses case with senior health officials • WHO urges priority for nations with low Covid vaccination rates Pfizer, the pharmaceutical company that […]
• Pharmaceutical company seeks FDA approval for third dose • Companies urged to instead prioritise less wealthy countries After a sharp increase in US Covid […]
Under fire for his government not reaching out to the pharmaceutical giant’s international head, health minister Greg Hunt also avoided naming the former Labor PM […]
With the COVID-19 delta variant has become the dominant strain circulating in the US, Pfizer and BioNTech have said they will ask the FDA and […]
The Israeli Ministry of Health has reported data suggesting that the efficacy of the Pfizer/BioNTech COVID-19 vaccine has become less effective at preventing the spread […]
Shots: Spero is eligible to receive $40M as an equity investment and ~$80M as development & sales milestones along with royalties on sales of SPR206 […]
Israel says technical issues have scuppered deal to give UK Covid vaccines expiring on 30 July Coronavirus – latest updates See all our coronavirus coverage […]
The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply […]
Casual vaccine chat is today’s only form of small talk, so it’s not surprising it would take a lightheartedly tribal turn. Ultimately, of course, gratitude […]
We look at the drug firms – led by Pfizer and Moderna – that are set to profit most in an unprecedented global vaccination drive […]
Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem Published: June 18, 2021 | Tags: Lineage, Option Agreement, […]
Shots: The STOP-COVID study was conducted with a research collaboration b/w Pfizer & an ARO in Brazil, evaluating the efficacy & safety of tofacitinib (10mg, […]
Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: […]
The US government will buy 500 million more doses of the Pfizer/BioNTech COVID-19 vaccine that will be given to around 100 countries via the COVAX […]
The FDA has approved Prevnar 20, a Pfizer vaccine that protects against 20 pneumococcal strains—seven more than the company’s blockbuster Prevnar 13. But others are […]
Pfizer has the FDA approval it was seeking for Prevnar 20, the latest update to its blockbuster pneumococcal vaccination franchise, keeping it one step ahead […]
Shots: The approval is based in the clinical program including P-I & II trials, and three P-III trials evaluating the safety & immunogenicity of Prevnar […]
Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021 Published: June 4, 2021 | Tags: […]
Imperial College London survey in 15 countries also reveals worries that vaccines had not been tested enough Coronavirus – latest updates See all our coronavirus […]
Shots: The approval is based on a P-III study assessing Comirnaty (two 30μg doses) in 2,260 participants aged 12-15yrs. and showed 100% efficacy in participants […]
Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug […]
Concert Pharmaceuticals has started the second of two planned phase 3 trials of its drug candidate for alopecia areata (AA), a common cause of hair […]
Myovant hormonal drug Myfembree has won FDA approval as a treatment for uterine fibroid bleeding. The regulatory decision clears the way for the pill to […]
Myovant has chalked up a second approval for its flagship drug relugolix from the FDA, becoming the first once-daily oral drug in the US to […]
Shots: The approval is based on efficacy and safety data from the P-III LIBERTY 1 & 2 studies assessing Myfembree (relugolix 40 mg, estradiol 1 […]
Moderna’s COVID-19 vaccine has joined the Pfizer/BioNTech jab in showing efficacy in younger patients in clinical trials, setting up an emergency use filing early next […]
Moderna becomes second manufacturer to announce successful trial results in younger people Coronavirus – latest updates See all our coronavirus coverage Mass vaccination of children […]
As US and EU health regulators review cases of heart inflammation seen in young people administered mRNA-based COVID-19 vaccines from Pfizer/BioNTech and Moderna, cardiologists have […]
Shots: The first enrolled patient has received their immunizations as part of a new study in adults ≥65yrs. evaluating the coadministration of 20vPnC with a […]
People who have received two doses of the AstraZeneca or Pfizer/BioNTech COVID-19 vaccines have good protection against the Indian variant of SARS-CoV-2 , according to […]
All seven COVID-19 vaccines ordered by the UK government will be tested in a new trial that will see whether they can be used as […]
AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency Published: May 14, 2021 | […]
Study finds antibodies against Sars-CoV-2 three-and-a-half times higher in people vaccinated again after 12 weeks rather than three Coronavirus – latest updates See all our […]
The first UK patient has enrolled on Pfizer’s phase 3 trial for its Duchenne muscular dystrophy (DMD) gene therapy. Pfizer’s CIFFREO study began in the […]
The pharmaceutical giant argues waiving intellectual property protections could see scarce inputs snapped up making it harder to produce vaccines Full Story podcast: Is Australia […]
The FDA has authorised Pfizer/BioNTech’s vaccine for 12- to 15 year-olds under emergency rules. In a statement the regulator said it had expanded the vaccine’s […]
Shots: The FDA has expanded the EUA for Pfizer’s COVID-19 vaccine in adolescents based on the data from the P- III trial in 2,260 participants […]
The FDA has expanded emergency use of the Pfizer/BioNTech Covid-19 vaccine to include children 12 to 15 years of age. Meanwhile, the regulator is planning […]
A review of side effects reported with coronavirus vaccines by the EMA’s safety committee has uncovered cases of inflammation of the heart in people receiving […]
The messenger RNA vaccine developed by Pfizer and BioNTech has been formally submitted for FDA approval. The application comes amid calls for all vaccine companies […]
Shares in Chinese and US companies fell sharply following announcement to boost production Coronavirus – latest updates See all our coronavirus coverage Shares in pharmaceutical […]
Shares in COVID-19 vaccine manufacturers have taken a hit after the US signalled its support for waiving patents on them, a moved aimed to boost […]
Pfizer expects revenues from its BioNTech-partnered COVID-19 vaccine to reach an eye-watering $26 billion this year, catapulting it to the top of the world’s biggest-selling […]
Vaccine will generate 73% more than forecast based on contracts signed until mid-April Coronavirus – latest updates See all our coronavirus coverage US drugmaker Pfizer […]
Shots: The P-II trial will evaluate the efficacy, safety, and tolerability of KN046 + Pfizer’s Inlyta (axitinib) as a 1L treatment of NSCLC. The 1EPs […]
More than 100 countries are pushing for a temporary waiver of IP rules to boost vaccine access for developing nations. Why hasn’t it been approved? […]
The UK has ordered an extra 60 million doses of the Pfizer/BioNTech COVID-19 vaccine, which could be used as a potential booster campaign in the […]
Health secretary says greater supplies of vaccine will help safeguard progress in tackling coronavirus Coronavirus – latest updates See all our coronavirus coverage The UK […]
Amplyx Pharmaceuticals brings Pfizer a clinical-stage antifungal candidate with a novel mechanism of action. The pharmaceutical giant is trying to build its antifungal product lineup, […]
In an interview with PharmaShots, Dr. Lara S. Sullivan, Chief Executive Officer, and Dr. Ronald Herbst, Chief Scientific Officer of Pyxis Oncology share insight on […]
As Valneva recruits volunteers for final stage trials of its vaccine, here is the current state of play in Britain Coronavirus – latest updates See […]
The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting […]
The UK’s unique offering as a life sciences research hub helped convince US biotech Novavax to develop its COVID-19 jab there, according to the head […]
The EU has continued a refocus of its COVID-19 vaccination drive on mRNA shots, ordering another 100 million doses of Pfizer and BioNTech’s Comirnaty shot. […]
A study has suggested that the risk of getting a serious brain clot is eight to 10 times higher in people with COVID-19 than those […]
Pfizer boss flags likelihood that extra jabs will be required – raising prospect of increased global demand Covid booster shot could be needed after nine […]
New strains such as the South African variant that’s emerged in south London will require constant vigilance as lockdown eases All viruses mutate. They do […]
Pfizer and Myovant have begun a late-stage trial of their potential uterine fibroid drug relugolix, as part of a contraceptive combination tablet. The FDA is […]
AstraZeneca’s Lynparza (olaparib) blazed a trail for the new class of PARP drugs when it was approved in 2014 to treat ovarian cancer. The drug […]
The coronavirus variant discovered in South Africa may evade Pfizer/BioNTech’s vaccine, according to a real-world data study conducted in Israel. Known as variant B.1.351, the […]
Experts say the development of blood clots after getting the jab is still an ‘exceedingly rare’ side effect. So what triggered the government’s change in […]
Despite having the global pandemic, the biopharma companies were involved in multiple M&A, licensing deals. The major focus of the year remains the production and […]
Half of UK adults have had a first jab, and future supplies of millions of doses look assured Coronavirus – latest updates See all our […]
Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19 Published: Apr 2, 2021 | Tags: Pfizer and BioNTech, Report, Results, BNT162b2, Prevent, COVID-19 Acceleron […]
Findings based on two doses three weeks apart are first to show shot remains effective for many months Coronavirus – latest updates See all our […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective […]
Based on the efficacy and safety data for their Covid-19 vaccine in younger teens, Pfizer and BioNTech plan to ask regulators to expand emergency authorization […]
Drug firm in partnership with BioNTech to seek US approval after trials found vaccine ‘well-tolerated’ in school-age children Pfizer plans to seek emergency approval for […]
Newly accused of data manipulation by the US, AstraZeneca has faced unprecedented scrutiny over the past six months Coronavirus – latest updates See all our […]
After more than a decade of fraught clinical development it looks like the end of the line for Pfizer/Lilly painkiller tanezumab, which promised to be […]
Pfizer has begun clinical development of an antiviral pill against COVID-19, which could be prescribed to patients at the first sign of infection. The company […]
After a long and troubled development the fate of Pfizer/Lilly’s tanezumab painkiller injection is in the balance ahead of a key meeting of advisers later […]
Vaccinating the world is the only way out of Covid, but a mixture of nationalism and protectionism is blocking the exit Covid-19 has proved to […]
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, […]
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, […]
Shots: Pfizer to receive an up front, equity in Pyxis and is eligible for development & commercial milestones as well as royalties on potential sales […]
Shots: Pfizer to receive an up front, equity in Pyxis and is eligible for development & commercial milestones as well as royalties on potential sales […]
Lisa Romano, MSN, RN, Chief Nursing Officer at CipherHealth The New Year brings hope and promises that an end to the COVID-19 pandemic is in […]
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 […]
As the COVID-19 vaccine roll-out gains in intensity, it has become common to hear people toss out the names of pharmaceutical companies like Pfizer, Moderna […]
EU regulators are reviewing reports of low blood platelets in patients who received any of the three approved COVID-19 vaccines from Pfizer/BioNTech, AstraZeneca and Moderna. […]
Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals […]
Jab has 97% efficacy against disease and death and 94% against infection without symptoms The Pfizer/BioNTech vaccine appears to give high protection against asymptomatic Covid-19, […]
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The […]
The rollout of the US COVID-19 vaccination programme slowed up this week because manufacturing delays mean no new doses of the recently approved Johnson & […]
A laboratory study suggests Pfizer and BioNTech’s COVID-19 vaccine Comirnaty could be effective against a Brazilian variant of the SARS-CoV-2 virus – known as P.1 […]
Özlem Türeci credits firm’s more than 50% female workforce for speed at which first viable jab created The co-founder and chief medical officer of BioNTech […]
The companies in line for the biggest gains – and the shareholders who have already made fortunes Coronavirus – latest updates See all our coronavirus […]
Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Published: Mar 5, 2021 | Tags: Eli Lilly […]
Shots: The approval is based on P-III CROWN study assessing Lorbrena vs Xalkori (crizotinib) monthx in 296 people in a ratio (1:1) with prior untreated […]
Joan Kapusnik-Uner PharmD, FCSHP, FASHP, VP of Clinical Content for First Databank (FDB) As the Biden administration ramps up its efforts to increase the access of […]
Both the Pfizer/BioNTech and Oxford University/AstraZeneca COVID-19 vaccines are highly effective in reducing COVID-19 infections among older people, according to an emerging study data. Data […]
Healthcare workers with obesity found to produce only about half the antibodies healthy people do Coronavirus – latest updates See all our coronavirus coverage The […]
Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Published: Feb 26, 2021 | Tags: Regeneron, Reports, […]
Therapeutic Goods Administration may follow US in allowing vaccines to be stored at warmer temperatures Pfizer’s Covid-19 vaccine could soon be delivered at temperatures 50 […]
Pfizer may have been making headlines with the COVID vaccine it developed with BioNTech, but it’s not the only infectious disease the big pharma is […]
Shots: The US FDA has accepted the PR of BLA for TicoVac to prevent TBE in patients aged ≥1year with an anticipated PDUFA date in […]
Factors at play include high uptake plus stockpiling for second doses, but Matt Hancock promises ‘bumper weeks in March’ Coronavirus – latest updates See all […]
Pfizer and BioNTech say they have data supporting two-week storage of their vaccine at temperatures found in medical-grade freezers. They say FDA approval of an […]
RedHill Signs a Manufacturing Agreement with Cosmo for Movantik and RHB-204 Published: Feb 19, 2021 | Tags: RedHill, Signs, Manufacturing, Agreement, Cosmo, Movantik, RHB-204 Astellas and […]
Two researchers have suggested that the second dose of Pfizer and BioNTech’s COVID-19 vaccine could be delayed, as this would increase the number of people […]
“Patent losses could sink Allergan”.1 “Drug prices to plummet in wave of expiring patents”.2 “Price decay after loss of brand exclusivity”.3 These are just three […]
The South African coronavirus variant may cut the effectiveness of Pfizer/BioNTech’s vaccine by around two thirds, according to a laboratory study. Researchers from the University […]
The European Commission has ordered another 200 million doses of the Pfizer/BioNTech COVID-19 vaccine Comirnaty, bringing the bloc’s total order to 500 million doses. Under […]
A news agency is claiming that North Korea launched a cyber-attack on Pfizer in a bid to steal information about its BioNTech-partnered COVID-19 vaccine, citing […]
New phase 3 data have shored up the position of Merck & Co’s cancer immunotherapy Keytruda in the increasingly competitive first-line kidney cancer market. The […]
Shots: The approval is based on the P-III study that involves assessing Panzyga (IVIg) in 142 patients with CIDP. The study evaluated more than one […]
The biopharma industry saw numerous deal terminations in 2020. Clinical and regulatory results, change in control limitations, and strategic reprioritizations were among the most common […]
The European Union has rubber-stamped its order for a further 300 million doses of Pfizer/BioNTech’s COVID-19 vaccine, according to press reports. Citing a European Commission […]
Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis Published: Feb 5, 2020 | Tags: Reiston, Report, Result, SHR0302, P-II, Study, Treat, […]
The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis […]
Shots: Imcyse to receive up front, ~$180M as milestones along with royalties. Pfizer to purchase an equity stake in Imcyse Initially, the companies will collaborate […]
New analysis runs counter to earlier study which suggested one dose may not give adequate protection Coronavirus – latest updates See all our coronavirus coverage […]
Roche Collaborate with Cambridge Quantum Computing to Develop Quantum Algorithm for Drug Discovery and Development Published: Jan 29, 2020 | Tags: Roche, Collaborate, Cambridge Quantum Computing, […]
JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. […]
JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. […]
UK vaccines taskforce has bought 60m doses after study found ‘spectacular results’ Coronavirus – latest updates See all our coronavirus coverage Another vaccine against Covid, […]
Shots: The post marketing Oral Surveillance involves assessing the safety of tofacitinib at two doses (5 mg, bid and 10mg, bid) vs TNFi in 4362 […]
Sanofi has said it is to begin manufacturing the COVID-19 shot from Pfizer and BioNTech in a week when supplies are in the spotlight. The […]
Chief executive of pharmaceutical giant says the firm will honour UK’s earlier contract despite EU anger over shortfall Coronavirus – latest updates See all our […]
Commission president says firms must deliver on orders after AstraZeneca warns of shortfall Coronavirus – latest updates See all our coronavirus coverage The EU “means […]
Ten of the world’s most infectious diseases identified by the WHO not being catered for by drug firms The world’s biggest pharmaceutical firms are little […]
The EU has hit back at AstraZeneca’s plan to provide fewer doses of its COVID-19 vaccine than expected, saying it wants to see exactly where […]
Pfizer and partner Merck KGaA now have approval on both sides of the Atlantic for their checkpoint inhibitor Bavencio as a first-line maintenance therapy for […]
Hot on the heels, Aurinia launches its drug in the Lupus market after GSK Aurinia Pharmaceuticals has recently got the USFDA approval for its Lupkynis […]
British Society for Immunology calls for a robust programme monitoring the body’s immune response Experts have called for greater clarity on the monitoring in place […]
British Society for Immunology calls for a robust programme monitoring the body’s immune response Experts have called for greater clarity on the monitoring in place […]
Exactly a year after his first story about coronavirus, our science editor received the Pfizer injection last week. Here he reflects on a remarkable scientific […]
Medics told they risk undermining public confidence by querying policy of three-month gap between doses Coronavirus – latest updates See all our coronavirus coverage Leading […]
Nations outbidding each other creates an ‘immoral race towards the abyss’ Coronavirus – latest updates See all our coronavirus coverage Pharmaceutical companies should do more […]
Kevin Grauman, President and CEO, QLess After months of uncertainty, hope is finally on the horizon as three viable COVID-19 vaccine candidates are moving closer […]
Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research […]
Laboratory studies have confirmed that antibodies stimulated by Pfizer and BioNTech’s COVID-19 vaccine can neutralise the new, more transmissible variant of SARS-CoV-2 identified in the […]
Surge in infections dampens optimism over country’s advanced immunisation programme Coronavirus – latest updates See all our coronavirus coverage Israel’s coronavirus tsar has warned that […]
Supplies of COVID-19 vaccines are in the spotlight as countries across the world step up their immunisation campaigns against the pandemic. As vaccine manufacturers face […]
Supply delays underline there was no legal or economic justification for central planning A storm is raging over the EU’s failure to have ordered more […]
Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one […]
A promise by president-elect Joe Biden to carry out 100 million coronavirus vaccinations in his first 100 days in power is “absolutely doable”, according to […]
Overall number of doses delivered between January and March will remain the same, the firm says Coronavirus – latest updates See all our coronavirus coverage […]
Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives […]
J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial […]
Shots: The approval is based on the ADVL0912 study assessing Xalkori in 121 patients aged 1-21yrs. that included 26 patients with r/r, systemic ALK+ ALCL […]
The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this […]
ViiV’s Tivicay is to become available in Europe in a new dispersible tablet form to treat children living with HIV. The joint venture, majority-owned by […]
The CEOs of Pfizer, Moderna, McKesson and CVS Health explained that the distribution effort has gone well but the administration of the vaccine has now […]
Hackers posted stolen confidential information about Pfizer/BioNTech’s COVID-19 vaccine online, the European Medicines Agency has said in an update. The EMA last month revealed that […]
Country will share data on its rapid vaccination campaign as ‘global model’, says PM Coronavirus – latest updates See all our coronavirus coverage One in […]
Bloc agrees deal for a further 300m doses as hopes are raised for speedier rate of inoculations Coronavirus – latest updates See all our coronavirus […]
Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies Published: Jan 7, 2020 | Tags: Almirall, Tyris, Collaborate, Develop, Next Generation, Gene Therapies Sarepta […]
Shots: The first patient has been dosed in P-III CIFFREO study assessing PF-06939926 vs PBO in 99 ambulatory male patients aged 4-7yrs. with DMD across […]
The Pfizer/BioNTech vaccine appears to work against an important mutation in the new coronavirus variants causing havoc in the UK and South Africa, according to […]
As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine […]
The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. With the UK […]
Shots: ImaginAb to receive license fees and payments for manufacturing and other support and will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer […]
ImaginAb has signed a deal with Pfizer, which it hopes will help it to gather information necessary for approval of its tumour imaging agent as […]
Shots: Dewpoint to receive up front payment and up to $239M as research, development & commercial milestones along with royalties on sales of the therapies […]
Pharma companies are always talking about moving ‘beyond the pill’, and Pfizer’s new brand identity embodies that – it’s decades old pill-like logo has been […]
Move to postpone second jab by up to 12 weeks is not supported by scientific evidence, experts find Coronavirus – latest updates See all our […]
Pfizer and OPKO Health: A step closer to FDA Nod for pediatric growth hormone deficiency (GHD) drug, Somatrogon Pfizer and Opko had joined hands in […]
Shots: The BLA submission is based on P-lll study assessing the safety and efficacy of Somatrogon (0.66 mg/kg, qw) vs Somatropin (0.034 mg/kg, qd) in […]
US experts warn against plan to give different second jab if supplies run low Coronavirus – latest updates See all our coronavirus coverage The UK […]
The effectiveness of delaying the second dose of Covid vaccines must be carefully monitored, argues Dr Grizelda George, while Jan Mortimer and Jenny van Tinteren […]
Firm races to fill potential gap left by bloc’s gamble on several vaccines being approved Coronavirus – latest updates See all our coronavirus coverage BioNtech […]
Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, […]
Analysis: regulator surprises by approving 12-week gap between first and second shots of vaccine as well as Pfizer/BioNTech shot Coronavirus – latest updates See all […]
The UK has approved AstraZeneca and Oxford University’s COVID-19 vaccine AZD1222 in another significant step forward in the fight against the pandemic, with first doses […]
From worst crash in a generation to record highs on news of a Covid vaccine, experts review the rollercoaster that was 2020 Coronavirus – latest […]
Rehovot Science Park What You Should Know: – Pfizer, AstraZeneca, Merck, and Teva, and Amazon Web Services (AWS) has been selected by the Israel Innovation […]
Shots: The US FDA has accepted for Priority Review the sNDA is based on the pivotal CROWN study and is being reviewed by the FDA […]
NHS England’s chief executive Sir Simon Stevens has said that all vulnerable people over the age of 50 will be offered a COVID-19 vaccine by […]
Shots: Myovant & Pfizer will jointly develop & commercialize ORGOVYX (relugolix) in advanced prostate cancer & if approved, relugolix combination tablet in women’s health in […]
A USD 4.2 Billion Myovant/ Pfizer Deal Myovant Sciences have decided to put their forces and efforts together to advance the Prostate cancer market as […]
Many medics ‘frustrated’ about low priority given to frontline staff at high risk of infection Coronavirus – latest updates See all our coronavirus coverage Frontline […]
The 2020 Observer Business Agenda Awards honour showoffs, light-touch founders and even … Big Pharma Each year, our awards celebrate the physical prowess of the […]
Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s […]
What You Should Know: – The American Medical Association (AMA) announced the addition of three Current Procedural Terminology (CPT) codes for AstraZeneca’s COVID-19 vaccine. The […]
Moderna is using a Roche antibody test in clinical trials of its Covid-19 vaccine. The test can measure the antibodies created through vaccination, offering a […]
Judges picked TrialSpark as the winner on the life sciences track of the pitch competition at MedCity’s virtual precision medicine conference. While the company is […]
Shots: The approval is based on P-ll/lll study involve the assessment of Comirnaty (BNT162b2) vs PBO in 44,000 patients aged ≥16 yrs. in the ratio […]
BioNTech CEO Ugur Sahin has said that it is “highly likely” the company’s COVID-19 vaccine will work against the more infectious strain circulating in the […]
The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which […]
Pharmaceutical companies complain of breach of confidentiality after amount EU has agreed to pay for leading vaccines goes public Coronavirus – latest updates See all […]
The FDA is looking to quickly approve Moderna’s COVID-19 vaccine after it was unanimously backed by a panel of experts. Yesterday’s advisory panel meeting voted […]
By creating new networks for 24/7 temperature monitoring, alerts and reporting, the challenges of deploying transportation at ultra-low temperatures can be overcome. This also illustrates […]
Trials of a fifth COVID-19 vaccine have begun in the UK, as IT issues threaten to delay the roll-out of the shot from Pfizer/BioNTech. France’s […]
With overall costs for vaccinating the UK population at £12bn, the public accounts committee flags ‘highly unusual’ arrangements Coronavirus – latest updates See all our […]
Hospitals in the US have started vaccinating their front-line staff against COVID-19, as deaths in the country crossed the 300,000 threshold with more than 200,000 […]
Gannex received US FDA fast track designation for its NASH drug, ASC42 an FXR Agonist Gannex Pharma has received Fast Track designation approval from FDA […]
The roll-out of the biggest vaccination programme in the history of the UK’s NHS is gathering pace, as family doctors and their teams begin taking […]
Shots: Pfizer & BioNTech received the US FDA’s EUA for BNT162b2 for patients aged ≥16yrs with COVID-19. The companies are gathering additional data & prepared […]
The vaccine was developed in record time, a big scientific accomplishment, even though the agency’s move follows an unusual level of pressure from President Trump’s […]
Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, […]
Advisers to the FDA have voted in favour of approving Pfizer and BioNTech’s COVID-19 vaccine, with a near-unanimous backing from an expert committee. While the […]
The challenge of delivering vaccines on this scale are hard, but are firmly within the world of logistics, engineering, and politics Coronavirus – latest updates […]
The nonbinding recommendation is a final hurdle before an official emergency use authorization for the vaccine, which could be the first shot approved for use […]
The European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s COVID-19 vaccine accessed. In a terse statement, […]
The global generics pharmaceutical market has become an intimidating segment of the pharmaceutical drug market which continuously growing and increasing with its accessibility & benefits […]
Shots: Health Canada has granted authorization under interim order for the emergency use of BNT162b2. The distribution of the vaccine in Canada will be prioritized […]
The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone […]
Anyone scheduled to receive vaccine will be asked about history of allergic reactions Coronavirus – latest updates See all our coronavirus coverage Regulators have issued […]
Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that […]
Billions unlikely to get jabs as rich countries secure 53% of most promising vaccines Coronavirus – latest updates See all our coronavirus coverage Nine out […]
Comments raise hopes that the vaccine could soon be available to Americans aged 16 and above US Food and Drug Administration (FDA) staff said on […]
A 90-year-old woman has become the first person given a COVID-19 vaccine as part of the UK’s mass vaccination programme. Margaret Keenan was given the […]
Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a […]
Medical director warns of great hurdles in largest vaccination campaign in UK history Coronavirus – latest updates See all our coronavirus coverage Batches of the […]
Vaccine safety message ‘vitally important’, head of medicines regulator tells Andrew Marr Show Coronavirus – latest updates See all our coronavirus coverage Public health messaging […]
We trace the extraordinary research effort, from the discovery of the virus’s structure to the start of inoculations this week Coronavirus – latest updates See […]
They make life-saving medicines, but no one likes them. Could this year be a turning point? Coronavirus – latest updates See all our coronavirus coverage […]
Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, […]
Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter […]
Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective […]
Shots: Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution […]
In the midst of the jubilation about the UK’s emergency approval of Pfizer/BioNTech’s COVID-19 shot in the UK came the depressingly inevitable round of anti-vaccine […]
Few companies embody the term ‘pharma giant’ as much as Pfizer. Here we take a look at the colourful history of one of the biggest […]
Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world […]
Shots: The companies have submitted CMA to the EMA for BNT162b2, against COVID-19. The submission completes the rolling review process initiated on Oct 6, 2020 […]
Covid vaccine with an efficacy of almost 95% has been authorised by the UK medicines regulator Coronavirus – latest updates See all our coronavirus coverage […]
Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the […]
The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine. According to […]
Pioneered by a Turkish-German couple, its significance exceeds its practical value The world took note when the German startup BioNTech announced its breakthrough in the […]
AstraZeneca may have tried a positive spin on the trial mistake that led to the accidental discovery of the low dose COVID-19 vaccine regime with […]
Results from clinical trials have shown that the world has three apparently highly effective vaccines for Covid-19. With the race now on for regulatory approval, […]
The partners pooled results from two trials and two different dosing regimens, one appearing to be more effective than the other. They hope to produce […]
AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. AZ made the […]
Plans for mass immunisation against Covid-19 are developing fast, but concerns must be addressed In the 1960s, academics studying rumours drew inspiration from epidemiology. They […]
Pharmaceutical partners submitted bid to the FDA for vaccine to be reviewed and emergency authorization may occur within weeks It could take as little as […]
Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19 Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli […]
Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end. The […]
Shots: The primary efficacy analysis demonstrated that BNT162b2 is 95% effective against COVID-19 beginning 28 days after the first dose. The study evaluated 170 confirmed […]
Among first 170 Covid cases in trial, eight had received vaccine and 162 were in placebo group Coronavirus – latest updates See all our coronavirus […]
The director’s next project after Da 5 Bloods is based on a 2018 Esquire article and will be co-written by Kwame Kwei-Armah Spike Lee is […]
Shots: Pfizer launched a pilot program to support the state’s planning, deployment & administration of the COVID-19 vaccine candidate, to build on coordination with the […]
Pfizer is preparing to file its COVID-19 vaccine after a trial reached the safety milestone required by US regulators for emergency use, according to press […]
Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by […]
While Pfizer/BioNTech’s version requires -75C storage, Moderna’s could be easier to roll out A second coronavirus vaccine candidate was always likely to struggle to match […]
Phase 3 success rate of 95% for US firm’s treatment is promising for UK vaccine trial Coronavirus – latest updates See all our coronavirus coverage […]
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