pharmaphorum

JULY 6, 2021

The UK’s biotechnology sector is going through a purple patch, attracting almost £1.6 billion ($2.2 billion) in financing in the three months to end-May – which is a record for the industry. The new figures – from the BioIndustry Association and Clarivate – were dominated by more than £1 billion in venture capital funding for UK biotech and life sciences companies, headlined by DNA sequencing company Oxford Nanopore’s £195 million raise in May that was just shy of the £205 million re

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Documentation Vaccines 141

Pharma Times

JULY 7, 2021

Eli Lilly and Boehringer Ingelheim have revealed positive results from a Phase III study of Jardiance in HFpEF patients

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NY Times

JULY 5, 2021

The World Bank said the financial crisis could rank among the world’s three worst since the mid-1800s. The currency has lost more than 90 percent of its value and unemployment has skyrocketed.

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Outsourcing Pharma

JULY 8, 2021

The immunotherapy firm is conducting a Phase III trial centered on an innovative approach to treating recurrent glioblastoma, an aggressive brain cancer.

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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.

pharmaphorum

JULY 9, 2021

Takeda’s Adam Zaeske discusses how cross-sector collaboration is shaping a brighter future for rare disease diagnosis. Diagnosis can sometimes be the most difficult part of a rare disease patient’s journey, and it’s with good reason that the process is often referred to as an ‘odyssey’ in these communities. “We’re dealing with very small populations of patients, on top of small populations of specialist physicians who are able to diagnose them,” says Adam Zaeske, formerly head of Rare Diseases,

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Medical Records Hospitals 120

Pharma Times

JULY 6, 2021

Vaccine will be evaluated in 13 HIV-negative adults aged 18-65 years old

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Vaccines 181

Outsourcing Pharma

JULY 9, 2021

During the Rare/Orphan Diseases, Special Patient Population webinar, a group of industry experts discussed challenges and opportunities faced in the field.

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pharmaphorum

JULY 6, 2021

A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. The interim readout from the 39-patient HERIZON trial found 50% of patients treated with the HER-Vaxx (IMU-131) vaccine on top of chemotherapy achieved a partial response or better, compared to 29% of patients given only chemo.

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Vaccines Chemotherapy Immunity Immunization 117

Pharma Times

JULY 8, 2021

Company is aiming to transform the discovery of therapeutics focused on enzyme inhibition

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Drug Patent Watch

JULY 7, 2021

Annual Drug Patent Expirations for XHANCE Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. There are thirteen patents protecting this drug. XHANCE drug…. The post New patent for Optinose Us drug XHANCE appeared first on DrugPatentWatch - Make Better Decisions.

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Pharmacy Management

NY Times

JULY 4, 2021

France is handing out third shots of the two-dose vaccines to cancer patients and others with immune system impairments. In the United States, patients like these are on their own.

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Immunity Immunization Vaccines 89

pharmaphorum

JULY 8, 2021

Artificial intelligence-based drug discovery company Exscientia is stepping up its search for new COVID-19 medicines, thanks to an award by the Bill & Melinda Gates Foundation. . The $1.5 million grant will be used to develop a new class of small-molecule inhibitors of M pro , a protease enzyme essential for the replication of the SARS-CoV-2 virus.

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Hospitals Vaccines 109

Pharma Times

JULY 8, 2021

Collaboration will focus on the development of smart neurostimulators for the treatment of severe chronic diseases

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Drug Patent Watch

JULY 7, 2021

Annual Drug Patent Expirations for MYCAMINE Mycamine is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. There is one patent protecting…. The post New patent expiration for Astellas drug MYCAMINE appeared first on DrugPatentWatch - Make Better Decisions.

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Outsourcing Pharma

JULY 9, 2021

A leader from IQVIA suggests what to look for when seeking ways to automate drug safety processes, while maintaining security and customer satisfaction.

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pharmaphorum

JULY 9, 2021

The EU medicines regulator has said that there is some evidence to suggest a possible link between mRNA-based vaccines for COVID-19 and rare cases of heart inflammation. . According to the EMA’s pharmacovigilance risk assessment committee (PRAC), labelling for Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax should be updated to reflect “very rare cases” of myocarditis and pericarditis with the shots.

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Vaccines Labelling Immunity Immunization 104

Pharma Times

JULY 8, 2021

COVID-19 infection rates were three times lower in fully vaccinated people compared to unvaccinated people

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Vaccines 129

NY Times

JULY 8, 2021

Scientists were critical of the announcement, pointing to evidence that the current two-dose regimen is powerfully effective against the coronavirus.

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Vaccines Immunity Immunization 98

Outsourcing Pharma

JULY 6, 2021

The two entities will work together to evaluate digital sensors and other tools used in clinical research, checking the items for accuracy and equity.

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pharmaphorum

JULY 9, 2021

Orchard Therapeutics’ gene therapy for rare childhood disease metachromatic leukodystrophy (MLD) Libmeldy has been rejected for NHS use by NICE in draft guidance. The agency said that while there was evidence of a short-term benefit with Libmeldy (atidarsagene autotemcel or OTL-200 ), assumptions about its long-term effects are uncertain, making it unclear whether it will offer value for money to the NHS.

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Compounding Immunity Immunization 104

Pharma Times

JULY 5, 2021

The Queen has awarded the ‘unprecedented’ honour to staff for their response to the COVID-19 pandemic

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NY Times

JULY 8, 2021

The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. The new label recommends that the drug be given only to patients with mild symptoms.

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Labelling 70

Outsourcing Pharma

JULY 8, 2021

The global contract research organization has announced it will be purchased by Goldman Sachs Asset Management and EQT Private Equity.

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pharmaphorum

JULY 8, 2021

GlaxoSmithKline’s head of oncology Axel Hoos has resigned from the company, and will take up a new role as chief executive of US biotech Scorpion Therapeutics. . Hoos is leaving GSK after nine years, a period that saw a complete revamp of the unit including the wholesale divestment of cancer drugs to Novartis in a $16 billion deal announced in 2014 – which completed as he took over the division.

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Compounding 104

Pharma Times

JULY 6, 2021

Almost £2m will be used for the first phase of the Avoiding Brain Injuries in Childbirth collaboration

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NY Times

JULY 6, 2021

In the latest shareholder lawsuit, a pension fund accused executives at Emergent BioSolutions of insider trading. The company, under investigation by Congress, has halted manufacturing of Covid-19 vaccines at its Baltimore factory at regulators’ request.

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Vaccines Immunity Immunization 67

Pharma Marketing Network

JULY 7, 2021

At this year’s Pharma USA conference, C ollaboration was the theme of the opening keynote session and a common thread woven throughout the event as industry leaders gathered to discuss how to move “Beyond Normal” to shape the future of health. In her opening statement, Izzy Gladstone, Reuters’ Head of Marketing, Pharma & Healthcare, challenged attendees to not return to our old ways of working.

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Vaccines 59

pharmaphorum

JULY 6, 2021

Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug. The US regulator issued Novartis with a complete response letter (CRL) for inclisiran in December, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy.

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Pharma Times

JULY 7, 2021

Checkpoint inhibitor has been approved to treat locally advanced cutaneous squamous cell carcinoma

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NY Times

JULY 8, 2021

The states, including Massachusetts and New York, agreed to drop opposition to the bankruptcy organization plan of the company, the maker of OxyContin.

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Drug Patent Watch

JULY 9, 2021

Annual Drug Patent Expirations for ALPHAGAN+P Alphagan P is a drug marketed by Allergan and is included in two NDAs. It is available from one supplier. There are eight patents…. The post New patent expiration for Allergan drug ALPHAGAN P appeared first on DrugPatentWatch - Make Better Decisions.

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pharmaphorum

JULY 7, 2021

The FDA indicated something was not well with Provention Bio’s filing for type 1 diabetes therapy teplizumab in April when it delayed its review. Now, the agency has rejected the application entirely, sending the company’s shares into a steep slide. The complete response letter (CRL) for teplizumab as a treatment to delay clinical type 1 diabetes in at-risk individuals reiterates the FDA’s concerns around the pharmacokinetics (PK) data for the antibody.

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Diabetes 98

Pharma Times

JULY 9, 2021

NHS bodies in Wales and Northern Ireland are now expected to consider providing access to SMA gene therapy

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NY Times

JULY 9, 2021

The agency’s acting head said a federal review should look into whether any interactions between agency staff and the drug developer, Biogen, broke F.D.A. rules.

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Drug Development 65

Drug Patent Watch

JULY 8, 2021

Annual Drug Patent Expirations for BRILINTA Brilinta is a drug marketed by Astrazeneca and is included in one NDA. It is available from two suppliers. There are four patents protecting…. The post New patent expiration for Astrazeneca drug BRILINTA appeared first on DrugPatentWatch - Make Better Decisions.

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