February, 2021

Bristol Myers finally wins FDA approval for cancer cell therapy

Bio Pharma Dive

Delays tied to factory inspections had pushed an FDA decision on Breyanzi past a key deadline, allowing Bristol Myers to avoid paying billions of dollars in payouts to investors

The health care industry should also invest more preventative health

World of DTC Marketing

SUMMARY: In a recent study by The Harris Poll on behalf of TIME, the overwhelming majority of Americans (78%) admitted to delaying routine medical services and health care appointments due to the coronavirus pandemic.

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How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product

Camargo

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high.

Can you get melatonin over the counter in the UK?

Druggist

Melatonin is a hormone that is released at night by the pineal gland located in the brain. Melatonin controls the sleep-wake cycle (24-hour cycle). In other words, melatonin acts as a biological clock that regulates sleep. Melatonin, therefore, can be used to promote and regulate sleep (Wagner et al.,

Need Health Insurance? Marketplaces are Open Now!

Triage Cancer

Health Insurance Marketplaces are now open for a Special Enrollment Period (SEP). In the 36 states with Marketplaces on www.HealthCare.gov, individuals have the opportunity to buy a new health insurance policy or change policies until May 15, 2021.

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Johnson & Johnson Will Test its Vaccine in Infants

NY Times

The company’s coming trials will also involve pregnant women and people whose immune systems are compromised. internal-essential Children and Childhood Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) Immune System Clinical Trials Vaccination and Immunization Babies and Infants Johnson & Johnson

FDA authorizes J&J's one-shot coronavirus vaccine

Bio Pharma Dive

The agency's emergency clearance makes J&J's vaccine the third available in the U.S., adding much-needed reinforcements at a critical time

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Top 5 Common Misconceptions About Meeting with the FDA

Camargo

Preparing to meet with the FDA can be challenging and stressful for sponsors, especially when they do not know what to expect. Many have misunderstandings about how meetings should be conducted and what constitutes success.

Pfizer/BioNTech to trial COVID-19 vaccine in pregnant women and children

BioPharma Reporter

Pfizer and BioNTech have dosed the first participants in a Phase 2/3 study for their COVID-19 vaccine in pregnant women; and plan to trial the vaccine in children later this year. Bio Developments

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Israel Real-World Study: Pfizer-BioNTech COVID-19 Vaccine Prevents 98.9% of Deaths

BioSpace

Israel’s Health Ministry announced results of a study in the country that showed that the Pfizer-BioNTech COVID-19 vaccine was 98.9% effective at preventing COVID-19 deaths

Climate impacts drive east-west divide in forest seed production

Scienmag

Western forests may be less able to regenerate following large-scale diebacks Credit: USGS DURHAM, N.C.

As COVID-19 becomes a business, vaccine makers confront thorny pricing questions

Bio Pharma Dive

Yearly vaccinations could be required after the pandemic ebbs. Will drugmakers change how they approach pricing their shots

The biggest threat to the pharma industry

World of DTC Marketing

SUMMARY: The biggest threat to the pharma industry isn’t the coming tsunami of healthcare changes. It’s reshaping the company to once again focus on patients instead of profits.

FDA Designations for Rare Disease Products, Part 2: Orphan Drug Designation

Camargo

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation.

Clinical trial set to test efficacy of mixing Sputnik V and COVID-19 Vaccine AstraZeneca

BioPharma Reporter

Health officials in Azerbaijan have granted approval for a clinical trial to take place in that country combining Russiaâs Sputnik V vaccine with the Oxford-AstraZeneca COVID-19 shot in adults 18 years and older. Markets & Regulations

COVID-19 Long-Hauler Therapy Space Beginning to Take Shape

BioSpace

While the space is just beginning to emerge, therapies for long-haul COVID-19 patients are still very much an unmet need

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DNA-based technique allows researchers to determine age of living beluga whales in Alaska

Scienmag

Credit: Paul Wade, NOAA Alaska Fisheries Science Center. NEWPORT, Ore. – Researchers can now determine the age and sex of living beluga whales in Alaska’s Cook Inlet thanks to a new DNA-based technique that uses information from small samples of skin tissue.

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Pfizer set to double weekly production of coronavirus vaccine

Bio Pharma Dive

The drugmaker will use production lines at its plant in McPherson, Kansas to help fill vaccine vials, company CEO Albert Bourla said Friday

Pharma throwing money away on digital ads

World of DTC Marketing

SUMMARY: Digital ad spend in pharmaceutical brands is up 111% so far in 2020 and 80% of that money is being thrown away by fraud and the popularity of programmatic advertising. While popular, digital advertising wasn’t an immediate hit in the pharmaceuticals arena due to the strict regulations.

In the News: January 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Previously Approved Oncology Drug Cleared for Rare Pediatric Indication.

AstraZeneca/Oxford to trial COVID-19 vaccine in children

BioPharma Reporter

A new trial for the AstraZeneca/Oxford COVID-19 vaccine will investigate the efficacy of the vaccine in children aged six and over. Bio Developments

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Triple Negative Breast Cancer Drug Development Digital Summit

Pharma Phorum

Improving the Safety, Efficacy & Predictability of Monotherapy & Combinatorial Therapies to Fast-track the Discovery & Development of TNBC Treatments to Reach Patients in Need.

Researchers find peptide that treats, prevents killer citrus disease

Scienmag

Treatment causes deadly bacterium to leak and die Credit: Hailing Jin/UCR New research affirms a unique peptide found in an Australian plant can destroy the No. 1 killer of citrus trees worldwide and help prevent infection.

FDA lays out shortened path for testing vaccines against new coronavirus variants

Bio Pharma Dive

Lengthy trials won't be needed for updating shots against emerging viral strains, the agency told developers in newly published guidance

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Jazz Pharma uses flying pig for huge grey area DTC

World of DTC Marketing

SUMMARY: One of the biggest complaints people have about their health is the lack of sleep caused by many factors, from diet and weight to chronic stress. DTC for a product that can keep people awake for nine hours is a message for potential abuse.

Semaglutide Brings Significant Weight Loss in Obese Patients

NY Times

In a clinical trial, participants taking semaglutide lost 15 percent of their body weight, on average. Obesity Diabetes Drugs (Pharmaceuticals) Clinical Trials Weight New England Journal of Medicine Northwestern University Novo Nordisk A/S

'Vaccines are working': UK unveils real-world data from vaccination campaign

BioPharma Reporter

Real-world data from England shows that the Pfizer/BioNTech vaccine offers 'clear protection from first dose' and may help interrupt transmission; while Scottish data shows the first doses of vaccines led to a substantial fall in hospital admissions. Bio Developments

Pfizer Accused of Holding Some Countries to “Ransom” Over COVID-19 Negotiations

BioSpace

Pfizer has been accused of bullying governments in Latin America over coronavirus disease 2019 (COVID-19) vaccine negotiations, a recent investigative article revealed

White paper reveals pathway for digital therapeutics use in Italy

Pharma Phorum

A white paper has outlined a pathway that could allow Italy to realise the potential of digital therapeutics (DTx). The official journal of the Smith Kline Foundation, Tendenze Nuove, has published the paper entitled “Digital Therapeutics, an Opportunity for Italy” earlier this month.

Moderna readies multi-pronged plan for coronavirus variants, ups vaccine production

Bio Pharma Dive

The biotech has delivered a newly developed booster shot to NIH scientists, and will test several other approaches to address emerging virus strains

Can J&J’s vaccine approval erase bad pharma?

World of DTC Marketing

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. Johnson & Johnson has paid $2.7

Family cancer experience informs eHealth company

Outsourcing Pharma

The founder of Andaman7âs leukemia diagnosis, and his sonâs experience with bone cancer, have helped inform the firm's tech and patient-centric approach. Clinical Development

State Drug Importation Bills Just Got More Personal in California

Pharmacy Checkers

With lies and deception, Big Pharma has used the threat posed by rogue websites and counterfeit drugs to push back against U.S. state legislation to gain access to lower drug prices in Canada.

McKinsey Settles for $573 Million Over Role in Opioid Crisis

NY Times

The consulting firm has reached the agreement with 47 states because of its advice to drugmakers, including Purdue Pharma, the manufacturer of OxyContin.

A history of Johnson & Johnson

Pharma Phorum

By most measures the single largest pharma company in the world, US-based Johnson & Johnson (J&J) is also arguably one of the most well-known drugmakers among the general public. .

A gene therapy pipeline takes shape for a cluster of rare diseases

Bio Pharma Dive

Lysosomal storage disorders, diseases of cellular metabolism gone wrong, are the focus of a fast-expanding lineup of experimental genetic medicines, a research boom that recalls biotech's roots

Pharma running online ads on vaccine misinformation sites

World of DTC Marketing

SUMMARY: More than 42,000 programmatic ads from 4,315 brands are running on websites spouting misinformation about the vaccine and COVID over the past year. Included in the programmatic ad errors is Pfizer, who developed a leading COVID vaccine. When will pharma stop using programmatic online ads?