Before you dive into your Thanksgiving feasts, Peer Review has some appointments to share:
→ Mike Macaluso will be taking a one-year medical leave of absence from his duties as chairman and CEO of Englewood, CO-based Ampio Pharmaceuticals after disclosing last month that he is undergoing treatment. Michael Martino took a seat at the board of directors at the time of that October announcement, and the company will now be entrusted to him as interim chairman and CEO while Macaluso is away. Ampio also revealed a month ago that COO Holli Cherevka was elevated to president and COO, while Howard Levy — a CSL Behring and Novo Nordisk vet who retired from Catalyst Biosciences this summer — was named CMO. Dicerna chairman Kevin Buchi has also been added to Ampio’s board of directors.
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Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs
Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.
Learn more about Avance ClinicReady here.
Contact us about your next study.
Download our Frost & Sullivan APAC CRO Report here.
The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.
Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.
Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.
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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)
As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.
GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.
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Prince Charles gives a speech at AstraZeneca’s Discovery Centre (DISC) unveiling, with Pascal Soriot
One of the biggest projects that Pascal Soriot initiated, all the way back in 2013, after he first took over as AstraZeneca’s CEO is finally complete.
AstraZeneca is formally unveiling its $1.34 billion (£1 billion) R&D campus in Cambridge, UK, a shiny new facility spanning 19,000 square meters in the southern part of the city. On top of 2,200 research scientists, it will also host a suite of robotics, high-throughput screening and AI-driven technology.
Horizon Therapeutics CEO Tim Walbert fronts the pharma company’s new
Horizon Therapeutics CEO Tim Walbert runs a rare disease company, but he’s also a patient. While his condition hasn’t been a secret, Walbert is stepping out for the first time as the face of rare disease in Horizon’s new corporate campaign called ‘It’s Personal.’
Or rather, as one of the faces of rare disease — other Horizon employees will also share their stories as patients and caregivers as part of the effort.
Walbert is familiar with the typical long path of rare disease patients. He was first diagnosed as a junior in college with an autoimmune disease similar to rheumatoid arthritis, but he spent another 10 years before receiving a second rare disease diagnosis. More recently, he unfortunately added the role of caregiver to a child with a rare disease when his 13-year-old son was diagnosed last year with two autoimmune conditions.
Walbert joined Horizon as CEO in 2008 after working at Abbott — now AbbVie — in immunology on the launch of anti-inflammatory biologic Humira. Before that he worked at Searle, now part of Pfizer, on pain med Celebrex. The then-fledging Horizon had only a handful of employees and no office space, literally working from Walbert’s living room.
Lately though, Horizon’s been on a tear. Despite a pair of major setbacks with the pandemic closing infusion centers just weeks after its key Tepezza thyroid eye disease approval and then later when Catalent cancelled Tepezza manufacturing slots to prioritize Covid-19 vaccine production, the company reported $820 million in Tepezza sales in 2020. That accounted for about 40% of the pharma’s record $2.2 billion in 2020 sales, blasting past $1.3 billion in 2019 sales.
While ‘It’s Personal’ is Horizon’s first corporate branding effort, the growing pharma company has long relied on direct-to-consumer advertising as a key part of its commercialization strategy. It’s also invested heavily in unbranded awareness campaigns including RareIs which began as a social media awareness campaign that’s evolved into a rare disease resource and support community platform.
Walbert recently talked to Endpoints MarketingRx senior editor Beth Snyder Bulik about Horizon’s new campaign, and the rare personal journey that’s helped steer his career.
How did the new ‘It’s Personal’ campaign come about? Can you talk about your personal connection and why you wanted to do it?
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If both its BioNTech-partnered Covid-19 vaccine and in-house antiviral live up to their full promises, Pfizer may be sitting on a $100 billion goldmine in 2022.
That’s according to SVB Leerink analyst Geoffrey Porges, who released his latest forecast early Tuesday complete with a lengthy breakdown of all the intricate factors going into his calculation. Bottom line: universal boosting and pediatric recommendations will shore up global Covid vaccine sales to $59 billion in 2021 and $48 billion in 2022, or $107 billion in cumulative sales.
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Supply chain issues and an inspection backlog have hindered manufacturing’s seemingly endless boom, following an influx of money. But a new threat looms over the industry: a strain of Windows malware.
BIO-ISAC, an international organization that addresses threats to the bio economy, issued the warning on its website Monday, saying that a ‘large biomanufacturing facility’ was involved in an attack in spring 2021, and the same malware was noticed at a second facility in October 2021. The organization expedited the threat advisory in the public’s interest and has issued a statement to manufacturers: Assume that you are a target, and review security protocol accordingly.
Neil Desai, Aadi Bioscience CEO (via YouTube)
The FDA on Tuesday approved Aadi Bioscience’s first drug and the first treatment approved specifically for patients with an ultra-rare and aggressive form of sarcoma that occurs mostly in women.
The approval of the drug, known as Fyarro, is for those with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), and is based on a Phase II trial.
Results showed an overall response rate as assessed by independent review of 39% (12/31), with two patients achieving a complete response after prolonged follow up, Aadi said. The company also said that among responders, 92% had a response lasting greater than or equal to six months; 67% had a response lasting greater than or equal to 12 months; and 58% had a response lasting greater than or equal to two years.
Pascal Soriot, AstraZeneca CEO (Chris Ratcliffe/Bloomberg via Getty Images)
While Europe is in the midst of a massive fourth Covid-19 surge, the UK has largely avoided the high levels of hospitalizations and deaths seen on the rest of the continent. And AstraZeneca CEO Pascal Soriot suggested Tuesday the reason for Britain’s better fortunes could be his company’s vaccine.
In a one-on-one interview with BBC Radio 4, a reporter asked Soriot whether he was disappointed over the UK’s decision not to use the AstraZeneca/Oxford shot as a booster. Soriot responded by touting the vaccine’s T cell response, saying some data have shown it may be more durable than mRNA shots in older people, where the focus had largely been on antibodies.
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