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The biotech still believes a speedy approval filing for the closely watched treatment is possible, but expects to have to wait for the results of the recently launched Phase 3 trial, CEO Doug Ingram said on a conference call MORE
Early study results offer some hopeful signs of efficacy, but the small number of patients treated and short follow-up limit firmer conclusions MORE
The gene editing company aims to expand its trial and add a second dose to improve effectiveness. However, safety worries have emerged since the FDA ordered CRISPR's rival Allogene to suspend clinical work MORE
As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. MORE
The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test MORE
The drugmaker, along with partner Ridgeback Biotherapeutics, plan to ask the FDA for emergency authorization "as soon as possible " MORE
On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice MORE
Approximately 79% of patients look to connect through social media to find answers to their health questions MORE
SUMMARY: 62% of HCPs spend 3 hours per day accessing digtal resources. More HCPs chose to use smartphones to access digital resources as well and usage has increased when accessing a wide variety of professional content. MORE
The Biden administration's call comes ahead of FDA authorization for additional doses in people who aren't immunocompromised, although agency head Janet Woodcock joined other officials in supporting the plan MORE
277 
Development and Reproductive Toxicology studies, or DART studies, are required for most non-oncology programs between IND and NDA filings. MORE
The adoption of digital health technologies (DHTs) in the industry continues to pave the way to enable decentralized clinical trials (DCTs MORE
Voyager Therapeutics recently scrapped much of its pipeline and replaced top executives. Now, a Pfizer deal on new technology gives investors hope MORE
In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19 MORE
Outside trial data reviewers have attributed three cases of severe muscle weakness to Pfizer’s treatment, causing the company to change the design of its closely watched Phase 3 study MORE
The next six months could feature clinical milestones for CRISPR gene editing, the treatment of COVID-19, microbiome drugs and gene-targeted cancer therapy MORE
A panel convened by the regulator suggested ways to make gene therapy research safer, but struggled to propose broader recommendations for the field MORE
The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used MORE
Just a few months out of stealth mode, Laronde and its "endless RNA" technology have caught the attention of well-known investors like Fidelity, T. Rowe Price Associates and Invus MORE
Agency advisers supported giving a third Pfizer vaccine dose to older adults and those with medical conditions. But in a break with the FDA, they voted against recommending it for younger people in high-risk jobs MORE
A number of drugmakers have recently faced development delays after the FDA's asked for more information on how they measure the potency of their products MORE
How and When to Incorporate PK Design into Your Gene Therapy Development Plan. Gene therapy, which was in its infancy around 30 years ago, is now becoming a more prominent treatment method in many therapeutic areas, from personalized therapy to mass vaccinations against COVID-19. MORE
For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective MORE
Initial study results for Relay's experimental treatment offer some support for the biotech's protein motion technology, but raise some questions, too MORE
SUMMARY: Anti-vaxxers are vocal, and the media amplify their voices. There are many reasons why people aren’t getting vaccinated. We need more data to understand why. Republican extremism is part of the problem, but so is the lack of education. MORE
After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech MORE
SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings. MORE
Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months MORE
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: Repurposed Transplant Drug Approved Based Only on Real-World Evidence. MORE
Results published in The New England Journal of Medicine offer the first clinical evidence that CRISPR gene editing inside the body can be safe and effective, a culmination of years of scientific research MORE
A group of advisers convened by the regulator will spend Thursday and Friday weighing a range of safety worries with gene therapy, and how best to prevent them MORE
If approved, TG's drug would join Roche's fast-selling Ocrevus and Novartis' newer entrant Kesimpta as one of a newer class of multiple sclerosis therapies MORE
A wide-ranging alliance between CRISPR Therapeutics and Nkarta is the latest sign of interest in a fast-emerging form of cancer immunotherapy MORE
285 
Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year MORE
Vividion Therapeutics was headed toward an IPO earlier this year, but a company executive said Bayer’s $1.5B offer ended up being a more attractive option MORE
282 
QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Coronaviruses were first encountered in April 1930, when a strange respiratory disease ravaged poultry farms across North Dakota and Minnesota, killing tens of thousands of baby birds. MORE
Marion Gruber and Phil Krause, two veteran vaccine reviewers, are unexpectedly leaving the agency at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter MORE
The acquisition is notable for Merck, which is under pressure to diversify its business beyond the cancer drug Keytruda and has typically favored smaller buyouts MORE
Bio Pharma Dive
OCTOBER 12, 2021
The gene editing company aims to expand its trial and add a second dose to improve effectiveness. However, safety worries have emerged since the FDA ordered CRISPR's rival Allogene to suspend clinical work
World of DTC Marketing
JULY 28, 2021
SUMMARY: 62% of HCPs spend 3 hours per day accessing digtal resources. More HCPs chose to use smartphones to access digital resources as well and usage has increased when accessing a wide variety of professional content.
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Camargo
AUGUST 18, 2021
Development and Reproductive Toxicology studies, or DART studies, are required for most non-oncology programs between IND and NDA filings.
Bio Pharma Dive
OCTOBER 8, 2021
Initial study results for Relay's experimental treatment offer some support for the biotech's protein motion technology, but raise some questions, too
Bio Pharma Dive
SEPTEMBER 15, 2021
Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months
Bio Pharma Dive
SEPTEMBER 7, 2021
On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice
Bio Pharma Dive
SEPTEMBER 1, 2021
Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year
Clinical Research Informer brings together the best content for pharmaceutical professionals from the widest variety of industry thought leaders.
Bio Pharma Dive
AUGUST 31, 2021
Marion Gruber and Phil Krause, two veteran vaccine reviewers, are unexpectedly leaving the agency at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter
Bio Pharma Dive
SEPTEMBER 29, 2021
Early study results offer some hopeful signs of efficacy, but the small number of patients treated and short follow-up limit firmer conclusions
Bio Pharma Dive
SEPTEMBER 14, 2021
The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used
Bio Pharma Dive
SEPTEMBER 23, 2021
Agency advisers supported giving a third Pfizer vaccine dose to older adults and those with medical conditions. But in a break with the FDA, they voted against recommending it for younger people in high-risk jobs
World of DTC Marketing
JULY 26, 2021
SUMMARY: Anti-vaxxers are vocal, and the media amplify their voices. There are many reasons why people aren’t getting vaccinated. We need more data to understand why. Republican extremism is part of the problem, but so is the lack of education.
Camargo
AUGUST 11, 2021
As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined.
Bio Pharma Dive
SEPTEMBER 17, 2021
In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19
Bio Pharma Dive
SEPTEMBER 30, 2021
The acquisition is notable for Merck, which is under pressure to diversify its business beyond the cancer drug Keytruda and has typically favored smaller buyouts
Bio Pharma Dive
AUGUST 4, 2021
Vividion Therapeutics was headed toward an IPO earlier this year, but a company executive said Bayer’s $1.5B offer ended up being a more attractive option
Bio Pharma Dive
JULY 9, 2021
After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech
Bio Pharma Dive
SEPTEMBER 28, 2021
Outside trial data reviewers have attributed three cases of severe muscle weakness to Pfizer’s treatment, causing the company to change the design of its closely watched Phase 3 study
Bio Pharma Dive
JUNE 26, 2021
Results published in The New England Journal of Medicine offer the first clinical evidence that CRISPR gene editing inside the body can be safe and effective, a culmination of years of scientific research
Bio Pharma Dive
JULY 26, 2021
Approximately 79% of patients look to connect through social media to find answers to their health questions
Bio Pharma Dive
AUGUST 18, 2021
The Biden administration's call comes ahead of FDA authorization for additional doses in people who aren't immunocompromised, although agency head Janet Woodcock joined other officials in supporting the plan
Bio Pharma Dive
JUNE 21, 2021
The next six months could feature clinical milestones for CRISPR gene editing, the treatment of COVID-19, microbiome drugs and gene-targeted cancer therapy
World of DTC Marketing
JUNE 6, 2021
SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings.
Camargo
AUGUST 5, 2021
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: Repurposed Transplant Drug Approved Based Only on Real-World Evidence.
Bio Pharma Dive
OCTOBER 11, 2021
The biotech still believes a speedy approval filing for the closely watched treatment is possible, but expects to have to wait for the results of the recently launched Phase 3 trial, CEO Doug Ingram said on a conference call
Bio Pharma Dive
OCTOBER 6, 2021
Voyager Therapeutics recently scrapped much of its pipeline and replaced top executives. Now, a Pfizer deal on new technology gives investors hope
Bio Pharma Dive
MAY 24, 2021
The adoption of digital health technologies (DHTs) in the industry continues to pave the way to enable decentralized clinical trials (DCTs
Bio Pharma Dive
AUGUST 30, 2021
Just a few months out of stealth mode, Laronde and its "endless RNA" technology have caught the attention of well-known investors like Fidelity, T. Rowe Price Associates and Invus
Bio Pharma Dive
MAY 6, 2021
A wide-ranging alliance between CRISPR Therapeutics and Nkarta is the latest sign of interest in a fast-emerging form of cancer immunotherapy
Bio Pharma Dive
MAY 19, 2021
A number of drugmakers have recently faced development delays after the FDA's asked for more information on how they measure the potency of their products
Bio Pharma Dive
MAY 28, 2021
For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective
Bio Pharma Dive
APRIL 19, 2021
If approved, TG's drug would join Roche's fast-selling Ocrevus and Novartis' newer entrant Kesimpta as one of a newer class of multiple sclerosis therapies
Bio Pharma Dive
SEPTEMBER 15, 2021
The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test
World of DTC Marketing
APRIL 11, 2021
QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Coronaviruses were first encountered in April 1930, when a strange respiratory disease ravaged poultry farms across North Dakota and Minnesota, killing tens of thousands of baby birds.
Camargo
JULY 27, 2021
How and When to Incorporate PK Design into Your Gene Therapy Development Plan. Gene therapy, which was in its infancy around 30 years ago, is now becoming a more prominent treatment method in many therapeutic areas, from personalized therapy to mass vaccinations against COVID-19.
Bio Pharma Dive
SEPTEMBER 1, 2021
A group of advisers convened by the regulator will spend Thursday and Friday weighing a range of safety worries with gene therapy, and how best to prevent them
Bio Pharma Dive
OCTOBER 1, 2021
The drugmaker, along with partner Ridgeback Biotherapeutics, plan to ask the FDA for emergency authorization "as soon as possible "
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