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therapeutics

Senator Bernie Sanders to Block NIH Nominee Until Biden Reveals Plan to Tackle High Drug Prices

June 14th, 2023|Categories: Featured, Industry News|Tags: , , , |

Senator Bernie Sanders (I – VT) will vote against the Biden’s pick for NIH director, Dr. Monica Bertagnolli, until the administration lays out plans to reduce high prescription drug prices in the US. This effectively blocks the nomination, as Sanders’ vote is necessary for it to pass. The administration argues that its commitment to lowering drug prices has already been demonstrated by the passage of the Inflation Reduction Act.

Ipsen’s Drug for Itching in Rare Liver Disease Gets Second Approval

June 14th, 2023|Categories: Industry News|Tags: , , , |

Ipsen’s drug Bvlay has gotten its second approval for itching (pruritis) in a rare liver disease, this time in Alagille syndrome. The drug had previously been approved for progressive familial intrahepatic cholestasis. Another indication may be on the way in the near future, as Ipsen is currently in late-stage testing for the drug in a childhood liver disorder.

End of the COVID-19 PHE Imperils Access to Cancer Drugs for Rural Patients

June 13th, 2023|Categories: Featured, Industry News|Tags: , , , |

Rule changes during the COVID-19 public health emergency (PHE) allowed cancer patients to have their drugs delivered to their home. With the end of the PHE, this change reverts back to pre-pandemic rules, which will force patients to pick up their medications every few months. This poses significant problems for rural patients, some of whom will have to drive 500 miles for their medications.

Atropos Health Shares Real-World Evidence Examining High vs Low-Cost Medications

June 13th, 2023|Categories: Featured, Industry News|Tags: , , , , |

In a poster session at this year’s American Society of Health-System Pharmacists (ASHP) meeting, Atropos Health presented real-world evidence examining the impact of prescribing high-cost vs low-cost medications on patient health outcomes. The study, which looked at electronic health records (EHR) taken between 2015 and 2021, found no difference in outcomes between drugs at different price brackets.

List of Medications Facing Inflation-Linked Rebates Increases

June 12th, 2023|Categories: Featured, Industry News|Tags: , , , , |

The Centers for Medicare and Medicaid Services (CMS) has expanded the list of drugs that will be subject to rebates tied to price increases that exceed the current rate of inflation. The number, which was previously 20, now stands at 43, and includes drugs for leukemia, lymphoma, and asthma from major manufacturers like Seagen, Amgen, and AstraZeneca.

FDA Advisory Committee Votes in Favor of Eisai, Biogen’s Leqembi

June 9th, 2023|Categories: Featured, Industry News|Tags: , , , |

An advisory committee for the US Food and Drug Administration (FDA) voted 6-0 in favor of full approval for Leqembi, Eisai and Biogen’s treatment for Alzheimer's disease. The decision was made based on results from the Clarity AD study, which the committee members believed strongly supported its clinical benefits for patients.

FDA Brief Supports Full Approval for Alzheimer’s Drug Leqembi

June 8th, 2023|Categories: Featured, Industry News|Tags: , , , |

In a newly released brief, the US Food and Drug Administration (FDA) vocalized support for the full approval of Eisai and Biogen’s Alzheimer's drug Leqembi. The brief, which comes before an FDA adcomm this Friday, June 9th, shows that the agency considers the drug’s efficacy well-supported by evidence from a recent study and that the risk of adverse events does not rule out full approval.

The Odds Don’t Favor Merck’s Drug Price Negotiation Lawsuit

June 8th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Merck filed suit against the Centers for Medicare and Medicaid Services (CMS) recently, marking the first pharmaceutical company to do so. However, according to Stephen L. Carter of Bloomberg, the lawsuit may be dead in the water. The reason, he argues, is the basis of the suit, which hinges on the idea that price caps equate to the government seizing private property without fair compensation and that the language of the bill is a violation of the First Amendment.

GSK’s RSV Vaccine Nabs First EU Approval of its Kind

June 7th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Glaxo-Smith Klein (GSK) has received approval by the European Commission for its respiratory syncytial virus (RSV) vaccine Arexvy in adults aged 60 and up. This marks the first EU approval of a vaccine for RSV vaccine. This puts them ahead of Pfizer, whose vaccine Abrysvo has yet to be approved in the EU.

First Lawsuit Against US Medicare Drug Pricing Negotiations Filed by Merck

June 6th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

The pharma giant Merck & Co has filed a lawsuit against the US government over upcoming Medicare drug pricing negotiations included in the Inflation Reduction Act passed last year. The company argues that the negotiations would violate their 5th Amendment rights by forcing them to provide drugs at prices lower than market value.

AstraZeneca Looking Toward Early Full Approval for Anticoagulant Reversal Medication

June 5th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Following positive results in a phase IV clinical trial, Astrazeneca is making moves to apply for full approval for its anticoagulant reversal drug Andexxa earlier than expected. Data from the trial, which is being ended early based on outside recommendations, showed that the drug was effective in patients on certain anticoagulants who are experiencing an intracranial hemorrhage.

Inflation Reduction Act R&D Cost Request May Prove Problematic

June 5th, 2023|Categories: Featured, Industry News|Tags: , , , , |

The US Inflation Reduction Act requires drugmakers to justify new drug prices based on the R&D costs needed to develop a therapeutic during drug pricing negotiations. However, this policy may be short-sighted, according to some experts, as it doesn’t account for the lost investments in failed drugs or the overall value provided to patients.

Bristol Myers Squibb’s Heart Medication Camzyos Receives NICE Recommendation

June 5th, 2023|Categories: Featured, Industry News|Tags: , , |

Bristol Myers Squibb (BMS) has received a recommendation for approval from the UK’s National Institute for Health and Care Excellence (NICE) for its heart drug Camzyos (mavacamten). The recommendation covers the use of the drug as a adjunct treatment for symtompatic obstructive hypertrophic cardiomyopathy, a condition of reduced blood flow caused by thickening of certain walls in the heart.

CMS Drug Price Negotiations Complicated by Therapeutic Alternatives Clause

June 5th, 2023|Categories: Featured, Industry News|Tags: , , , , |

As part of the upcoming drug pricing negotiations from the Inflation Reduction Act, drugmakers will need to justify high US drug prices by comparing efficacy and value with therapeutic alternatives. The problem, according to industry leaders, is that the definition of therapeutic alternatives is unclear. Beyond that, these filings have a small max word count, making applications even trickier.

EMA Calls for Novartis’ Sickle Cell Treatment to Lose Market Authorization

June 2nd, 2023|Categories: Featured, Industry News|Tags: , , , , |

Novartis took a hit this week as the European Medicines Agency (EMA) has recommended that its market authorization for Adakveo, a sickle cell medication, be revoked. Although initial data suggested the drug could help reduce pain crises in patients 16 and older, the agency argues that new data showing increased levels of serious side effects do not outweigh the modest treatment effect.

Better Employee Health Through Specialty Rx Carve-Outs

June 2nd, 2023|Categories: Featured, Industry News|Tags: , , , , |

Specialty Rx carve-outs allow for dedicated management of high-cost specialty medications by bypassing traditional pharmacy benefit managers (PBMs). Doing so, according to a new article in Corporate Wellness Magazine, can help improve employee health by applying specialized expertise to coverage decisions, better coordinating care management, and reducing costs.

Molecular Templates’ Multiple Myeloma Trial Partial Hold Lifted

June 1st, 2023|Categories: Featured, Industry News|Tags: , , , |

Molecular Templates’ clinical trial for MT-0169, its experimental multiple myeloma therapeutic, is back on, following the US Food and Drug Administration (FDA) lifting a partial hold. The hold was placed on the trial following two adverse events experienced by patients, who both recovered. The move comes after the company laid off half its employees to focus on this drug, along with two others.

Pfizer’s RSV Vaccine Gets FDA Approval

June 1st, 2023|Categories: Featured, Industry News|Tags: , , , , |

The US Food and Drug Administration (FDA) has given approval for the use of Pfizer’s respiratory syncytial virus (RSV) vaccine in older adults. The move comes shortly after the agency approved another RSV vaccine from GSK. This sets up a marketplace standoff between the two, competing over a market that’s estimated at $17 billion.

Canadian Health Officials Tried to Hide Evidence Health Minister Stalled Drug Pricing Reform

May 31st, 2023|Categories: Featured, Industry News|Tags: , , , , |

Recently released emails show that Health Canada officials tried to hide a letter from Health Minister Jean-Yves Duclos to the Patented Medicines Prices Review Board (PMPRB), Canada’s independent drug pricing agency, asking them to delay drug pricing reform last year. The letter mirrored the pharma industry’s concerns and led to the reform being postponed.

Patients Turning to Illegal Pharmacies for Essential Medications

May 30th, 2023|Categories: Featured, Industry News|Tags: , , , |

US patients are increasingly turning to illegal pharmacies due to high prescription drug prices and shortages of essential medications. The issue has grown in recent years, catching the eyes of officials at the US Food and Drug Administration. It is especially concerning for the attention deficit hyperactivity disorder drug Adderall, which is currently difficult to impossible to find at many legal pharmacies.

Real-World Data Backs Dolutegravir Combo Therapies for HIV

May 30th, 2023|Categories: Featured, Industry News|Tags: , , |

A real-world data study published in AIDS found that three two-drug dolutegravir combination therapies were as effective in managing HIV as commonly used three-drug treatment regimens. The study covered over 3,000 patients from 2015 and 2021 taking dolutegravir in combination with lamivudine, rilpivirine, and emtricitabine.

Speaking with the Person Behind the Inflation Reduction Act Drug Price Negotiations

May 30th, 2023|Categories: Featured, Industry News|Tags: , , , , |

The US drug pricing reform in the Inflation Reduction Act was concocted by John Barkett of the Berkely Research Group. In a new interview, Politico’s Ben Leonard spoke to Barkett to talk about the process and the next steps for the Centers for Medicare and Medicaid Services (CMS). Barkett first spoke about pharma’s criticism of the move and the agency.

Looking at Real-World Data Supporting Durvalumab in NSCLC

May 26th, 2023|Categories: Featured, Industry News|Tags: , , , |

In a new Targeted Oncology Case-Based Roundtable, clinicians discussed new real-world data (RWD) supporting the use of durvalumab in unresectable stage III non-small cell lung cancer (NSCLC). The clinicians discussed their use of the immunotherapy, noting that most of them continued the treatment for 12 months, the length of treatment used in the observational study.

US FDA Fast Tracks Antithrombotic from BMS and J&J

May 26th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Johnson & Johnson and Bristol Meyer’s Squibb’s (BMS’s) antithrombotic milvexian has been fast tracked by the US Food and Drug Administration for three indications, according to the companies. The drug received the designation for the drug for stroke, atrial fibrillation, and acute coronary syndrome. Fast track designation is often granted for drugs that address medical conditions with limited treatment options.

US FDA Approves Paxlovid for High-Risk Adults

May 26th, 2023|Categories: Featured, Industry News|Tags: , , , |

The US Food and Drug Administration (FDA) approved Pfizer’s Paxlovid for patients at high risk of severe COVID-19 this week. The move is based on a randomized clinical trial that found that unvaccinated patients who had not been infected by COVID-19 before were 86% less likely to be hospitalized if given Paxlovid early in the disease. However, some experts have expressed concern over whether these results will translate to people who are up-to-date on their vaccinations.

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