NY Times
DECEMBER 11, 2020
British health officials recommended that people with severe allergy reactions not be given the vaccine. Such reactions to vaccines are rare, even in people who have allergies to food or bee stings.
pharmaphorum
DECEMBER 8, 2020
Novartis has signed a multi-year agreement with RetinAI Medical, which will see the companies work together to use artificial intelligence (AI) tools to support ophthalmology and digital health projects. Both companies have already worked on pilot projects in this area. The first project under a new master agreement will involve a multi-centre international clinical study involving patients with neovascular age-related macular degeneration (nAMD).
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Pharma Times
DECEMBER 9, 2020
ZUMA-12 phase II study is evaluating therapy as a first-line treatment for high-risk large B-cell lymphoma
Outsourcing Pharma
DECEMBER 8, 2020
An expert from the clinical research technology specialist discusses how trial teams can use real-world evidence to improve study inclusivity.
Speaker: Chris Antypas and Josh Halladay
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
NY Times
DECEMBER 8, 2020
The Oxford-AstraZeneca effort held great promise to help arrest the pandemic. But a series of miscues caused it to fall behind in the U.S.
pharmaphorum
DECEMBER 9, 2020
COVID-19’s knock-on effect on cancer patients is of concern by HCPs, with delayed or decreased diagnosis seen as a key worry. CREATION.co’s Lara Meyer explores why HCPs need more support. The COVID-19 pandemic has been mainstream headline news throughout 2020 and continues to have a profound impact on all our lives. A key concern that has emerged from the crisis is how COVID-19 will affect other areas of healthcare, particularly cancer diagnosis and treatment.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
Eye on FDA
DECEMBER 10, 2020
Sometimes in the midst of events, perspective is elusive. Today the Food and Drug Administration will hold a meeting of the Vaccines and Related Biologics Advisory Committee (VRBAC) to consider the application for an Emergency Use Authorization (EUA) submitted by Pfizer/BioNTech for their investigative vaccine for COVID-19. Usually prior to an FDA Advisory Committee meeting where a product is being considered for approval, the posting of the FDA Reviewer comments is greatly anticipated for what
Drug Patent Watch
DECEMBER 9, 2020
Annual Drug Patent Expirations for VYXEOS Vyxeos is a drug marketed by Celator Pharms and is included in one NDA. It is available from one supplier. There are eight patents…. The post New patent for Celator Pharms drug VYXEOS appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
DECEMBER 10, 2020
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 EU regulator confirmed its security had been breached and said it had launched an investigation with law enforcement, but would not be providing any additional information while that probe was underway.
Pharma Times
DECEMBER 9, 2020
Agreement will utilise RetinAI's IT solutions and artificial intelligence tools to support projects in ophthalmology
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NY Times
DECEMBER 7, 2020
The British-Swedish drugmaker has joined with a huge Asian company to produce a Covid-19 vaccine in China, where shady reputations are common in the pharmaceutical industry.
Drug Patent Watch
DECEMBER 10, 2020
Annual Drug Patent Expirations for ARISTADA+INITIO+KIT Aristada Initio Kit is a drug marketed by Alkermes Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Alkermes Inc drug ARISTADA INITIO KIT appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
DECEMBER 9, 2020
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 there are still uncertainties about whether the shot can stop the disease from spreading. The gist of a briefing document published from FDA reviewers ahead of an expert advisory board meeting is that the vaccine is good to go.
Pharma Times
DECEMBER 10, 2020
Updated guidance warns people with a history of allergic reactions not to receive the shot
NY Times
DECEMBER 8, 2020
The firm faced criticism after a report revealed that consultants had discussed destroying documents related to the opioid business and proposed that a drugmaker pay its distributors rebates for overdoses.
Outsourcing Pharma
DECEMBER 10, 2020
Health Decisions and OncoBay Clinical will collaborate on specialized clinical development services addressing therapies for womenâs cancers.
pharmaphorum
DECEMBER 11, 2020
Embedding diversity into clinical research does not start and end at trial recruitment – the community needs processes and institutions that reflect society and provide representation. Greater representation among study designers, research teams, and funding committees would lead to greater diversity among research participants and help to tackle health inequalities.
Pharma Times
DECEMBER 9, 2020
'Encouraging' data for investigational candidates across a range of blood cancers
NY Times
DECEMBER 11, 2020
A February conference by the drug company Biogen was initially thought to have infected 99 people. By the end of October, it was feared that the number had grown as high as 300,000.
Outsourcing Pharma
DECEMBER 7, 2020
A leader from data-centric CRO Quanticate shares perspective on how the pandemic has disrupted trials, and what tools and technologies can keep work going.
pharmaphorum
DECEMBER 10, 2020
UK digital health firm Sensyne has secured access to millions more anonymised patent records via an alliance with US clinical trial data specialist Phesi. The new agreement comes after a string of access deals with NHS trusts for patient data, and coincides with a bid by Sensyne to raise £27.5 million (around $37 million) through a 90 pence per share placing.
Pharma Times
DECEMBER 8, 2020
A 90 year-old woman in Coventry has become the first person in the UK to be given the vaccine
NY Times
DECEMBER 8, 2020
Dr. Chris Hingston was one of the first health care workers in Britain to receive a vaccination. He hopes that widespread use of the shots means that “life will change back to some normality.”.
Outsourcing Pharma
DECEMBER 10, 2020
The companyâs cancer drug, devimistat, has received orphan status from the agency for treating clear-cell sarcoma, pancreatic cancer, and other diseases.
pharmaphorum
DECEMBER 8, 2020
Amanda Barrell speaks to Alfred Samuels on his experience of prostate cancer and diversifying clinical trials to include the Black, Asian and minority ethnic (BAME) community. Alfred Samuels’ stage 4 metastatic prostate cancer brought his 30-year career, which had seen him travel the world with the likes of Beyoncé, Oasis, and Bob Dylan, to a shuddering halt.
Pharma Times
DECEMBER 11, 2020
ALK inhibitor recommended in the first-line non-small cell lung cancer setting
NY Times
DECEMBER 8, 2020
Queasy Americans, fighting upset stomachs and worries about the pandemic, have stocked up on prescription and over-the-counter medications, making them scarce in some parts of the country.
Outsourcing Pharma
DECEMBER 10, 2020
Through organizations like the Association of Clinical Research Organizations, clinical research professionals are helping decentralized research evolve.
pharmaphorum
DECEMBER 9, 2020
Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, but GlaxoSmithKline’s Nucala is now breathing down its neck. The FDA has started its review of Nucala (mepolizumab) for the inflammatory condition, which results in the growth of nasal polyps in the nose that can obstruct airflow and cause mucus discharge, sometimes requiring surgical intervention.
Pharma Times
DECEMBER 9, 2020
Vaccine candidate previously scored fast-track and breakthrough therapy designations
NY Times
DECEMBER 7, 2020
Otherwise, there won’t be enough shots to go around, even in rich countries.
Pharma Marketing Network
DECEMBER 7, 2020
Tune in now to listen to Darshan Talks Podcast, What a Clinical Trial Transparency Program Is (and Why You Need One). The post What a Clinical Trial Transparency Program Is (and Why You Need One) appeared first on Pharma Marketing Network.
pharmaphorum
DECEMBER 10, 2020
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 to serious allergic reactions. Moncef Slaoui, co-head of the US government’s Operation Warp Speed COVID-19 vaccine programme, made the comments after the UK drugs regulator advised those with severe allergies to avoid the vaccine.
Pharma Times
DECEMBER 7, 2020
The drug is administered intravaginally as a local oestrogen therapy for treatment of vaginal atrophy due to oestrogen deficiency.
NY Times
DECEMBER 9, 2020
But the announcement by the United Arab Emirates was met with silence from the Chinese vaccine maker, and raised more questions.
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