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US Senate Finance Chair Wyden Asks CMS to Enact Inflation Rebates

February 3rd, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

Although the Inflation Reduction Act includes a provision that makes drugmakers provide rebates to US Centers for Medicare and Medicaid Services (CMS) if they hike prices at a rate exceeding inflation, no such penalties have yet been divvied out. This week, Sen. Ron Wyden (D-OR), Senate Finance Chair, penned a letter asking the head of CMS when the rebates would kick in, emphasizing the need for quick action as many drug prices jumped significantly higher than the current rate of inflation in the past month.

Orphan Drugs Lead Specialty Medication FDA Approvals

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

Specialty medications currently lead the charts in terms of new drug approvals by the US Food and Drug Administration (FDA). On top of the heap are orphan drugs, treatments for rare diseases or those with no current therapeutics. In a new Pharmacy Practice News article, learn more about the orphan drugs in the approval pipeline for 2023.

First Humira Biosimilar Finally Hits Pharmacies with Two Price Points

February 1st, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

After a 20-year monopoly on the market, AbbVie’s Humira has lost exclusivity with the entrance of Amgen’s biosimilar, Amjevita. This marks the beginning of the end of the $114 billion rheumatoid arthritis drug’s dominance, propped up by widely critiqued patent thicketing. The biosimilar will follow a dual pricing system that, at best, will be half the cost of brand name Humira.

FDA Approves Two New Treatments for Breast Cancer and Lymphoma

January 31st, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

Eli Lilly and the Menarini Group have both gotten the nod from the US Food and Drug Administration (FDA) for their new cancer medications. Lilly’s therapeutic for relapsed or refractory mantle cell lymphoma, called Jaypirca, is only the fourth drug of its kind approved by the agency. It will cost $21,000 per month of treatment.

US Senator Elizabeth Warren Asks FTC to Investigate Two Pharma Mergers

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

US Senator Elizabeth Warren (D-MA) has expressed her concerns regarding two upcoming major pharma mergers, calling for the Federal Trade Commission (FTC) to investigate them. The two mergers are Amgen’s planned acquisition of Horizon Therapeutics for $28 billion and Indivior’s $145 million buyout of Opiant, the current owner of the opioid overdose rescue medication Narcan.

US Court of Appeals Sides with Pharma Over HHS on 340B Case

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

A US Court of Appeals ruled in favor of AstraZeneca, Novo Nordisk, and Sanofi in a case over the 340B Drug Pricing Program. The court decided that the companies could not be held responsible to provide the discounts mandated by the program at an unlimited number of pharmacies serving under-insured, lower-income communities.

Pharma Prepares for Bernie Sanders as US Senate Health Committee Chairman

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

US Senator Bernie Sanders (I-VT) has decried prescription drug prices and insurer practices throughout his political career. Now, as chairman of the Senate health committee, he will guide hearings and investigations into major pharma companies, pharmacy benefit managers (PBMs), and insurers. Industry sources say that companies are bracing themselves for the public image impact of these hearings, although they may face little actionable repercussions.

South Korean Pharma Industry Group Asks Government for Industry Steering Committee

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

According to the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), an industry group comprised of pharma companies based in South Korea, the nation should establish a steering committee helmed by industry leaders. The committee, according to KPBMA Chairman Won Hee-mok, would work with the government in policy-making regarding pharma and biotech products and services, as well as synchronizing strategies between health authorities and the industry.

Almost 1,000 US Drug Prices Hiked So Far in 2023

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

Drugmakers have raised the price of almost 1,000 prescription drugs this past month alone. These price hikes are anything but transparent for patients, as they are often obfuscated by complicated rebate schemes and reimbursement practices. Some lay the blame on upcoming provisions of the Inflation Reduction Act, implying that prices will be hiked progressively in preparation for drug pricing reform.

J&J and Legend’s CAR-T Therapy Better Than Standard Care in Phase III Trial

January 27th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

J&J and Legend Biotech have announced new results from their CARTITUDE-4 trial that shows their new CAR-T therapy Carvykti is more effective at treating multiple myeloma than standard care. The companies say that the therapy, which many predict to be an upcoming blockbuster, has achieved the trials primary endpoint of progression-free survival.

Using the UK’s Innovative Medicines Fund to Accelerate Rare Disease Drug Development and Access

January 27th, 2023|Categories: Featured, Industry News|Tags: , , , , |

The UK’s Innovative Medicines Fund (IMF) was started in collaboration with the NHS England and National Institute for Health and Care Excellence (NICE) to provide novel medicines with unresolved uncertainties to patients with rare non-cancer diseases that have little treatment options. In doing so, the program is intended to incentivized development of drugs for rare diseases, or orphan drugs.

US Sen. Warren Calls for March-In Rights for Prostate Cancer Drug

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

Elizabeth Warren (D-MA) and 25 other US senators wrote a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra requesting that the agency implements march-in rights for Astellas’ and Pfizer’s prostate cancer drug Xtandi. This would allow the federal government to take ownership of the drug’s license on the basis that government funding paid for part of its development.

Amazon Launches RxPass Service for $5 Generic Drugs

January 25th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Amazon has announced the launch of its RxPass service, a subscription-based prescription drug service that will ship certain generic medications to patients for $50 a month. The program includes over 50 generics and is integrated into existing Amazon Prime subscriptions. Drugs can be delivered monthly or once every three months, as requested.

Sanofi Sets Up Warranty Program for Discontinued Rare Disease Treatment

January 23rd, 2023|Categories: Featured, Industry News|Tags: , , , , |

Sanofi has set up a warranty program to pay back some medical institutions who administered Cablivi, an antibody-based treatment for a rare clotting disease. The company will reimburse healthcare institutions the cost of 6 doses for patients who do not see improvements and 12 doses for patients whose conditions worsen during treatment

Pharma Bro Martin Shkreli in Hot Water with FTC Over Lifetime Industry Ban

January 23rd, 2023|Categories: Featured, Industry News|Tags: , , , |

Martin Shkreli is once again in trouble with the FTC, this time over a potential violation of his lifetime ban from the pharma industry. Shkreli, who famously jacked the price of a niche malaria medicine from $18 to $750 per pill, appears to the agency to be side-skirting his industry ban for securities fraud charges by starting up a new drug discovery company within weeks of leaving prison.

Crescendo Health Gets $3.4 Million to Support Clinical Trials with Real-World Data

January 20th, 2023|Categories: Featured, Industry News|Tags: , |

The startup Crescendo Health has announced it received funding totalling $3.4 million to expand its real-world data (RWD) offerings. The company launched a platform that allows researchers and clinicians to integrate healthcare data from electronic health records (EHR), payer records, pharmacy claims, and more with clinical trial data to accelerate research and therapeutic development.

BioPharma Dive 2023 Biotech Executive Outlooks

January 20th, 2023|Categories: Featured, Industry News|Tags: , , , |

In a new BioPharma Dive panel hosted at this year’s J.P. Morgan Healthcare Conference, executives from ABIO-X, Ovid Therapeutics, and Lifemine Therapeutics spoke about their projections for the new year. Their outlook was somewhat tempered by the current down market and prospects of drug pricing reform, but they were at least somewhat optimistic.

Ipsen CEO Talks Rare Disease Therapeutic Development and the Risks of Gene Therapy

January 18th, 2023|Categories: Featured, Industry News|Tags: , , , , |

David Loew, CEO of Ipsen, spoke at the JP Morgan Healthcare Conference about his outlook on the rare disease field. Loew noted that Ipsen was leaning into the market full-steam, regardless of pressure from Big Pharma companies attempting to crowd the space. That said, the CEO was more cautious on the gene therapy and neuroscience fronts.

NHS Confederation and ABPI Report Recommends Collaboration to Increase Access to Innovative Therapeutics

January 17th, 2023|Categories: Featured, Industry News|Tags: , , , |

A newly published report from the NHS Confederation and Association of the British Pharmaceutical Industry (ABPI) indicates that collaboration between the NHS and pharma can help improve patient access to innovative treatments. The report noted that uptake of novel therapeutics was often stunted by a variety of barriers, systemic and situational. However, some examples of effective partnerships were discussed.

FDA – Last Week in Review

January 16th, 2023|Categories: Featured, Industry News|Tags: , , , |

Last week, the US Food and Drug Administration (FDA) made key decisions regarding the approval of multiple medications and accepted submissions of a few others. First, the agency approved the use of semaglutide as a first-line diabetes therapy. In addition, it accepted the application for brexpiprazole in treating agitation related to Alzheimer’s disease. It wasn’t the only application for the treatment of the otherwise intractable disease.

Pharma Industry to Continue Facing Inflationary Pressure Through 2023

January 16th, 2023|Categories: Featured, Industry News|Tags: , , |

High inflation rates will continue battering the pharma industry throughout 2023, according to a new Pharmaceutical Technology article. Although inflation appears to be abating in the US this year, it may fall more slowly abroad, impacting growth. In addition, drug pricing reform in the US weighs heavily on the industry’s minds, despite changes not being implemented until 2026.

State of California Files Suit Against Pharma Companies and PBMs Over High Insulin Pricing

January 16th, 2023|Categories: Featured, Industry News|Tags: , , , , |

The US state of California has filed suit against major pharmacy benefit managers (PBMs) and the biggest manufacturers of insulin over high prices. The state argues that the companies have undue influence over the market as major players and leverage the relative lack of competition to keep prices of the live-saving drug at exorbitant levels despite the cheap cost of production.

AbbVie and Eli Lilly Exit Voluntary UK Drug Pricing Agreement

January 16th, 2023|Categories: Featured, Industry News|Tags: , , , , |

The pharma giants AbbVie and Eli Lilly have backed out of an agreement between the UK government and Association of the British Pharmaceutical Industry (ABPI) that capped spending growth of branded medications to the NHS at 2% per year. The ABPI maintains that the government program’s requirements are behind the companies’ exits.

Ipsen Will Acquire Albireo to Expand Rare Disease Drug Pipeline

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

The French biopharma company Ipsen has announced the future acquisition of Albireo, a company specializing in drugs for rare diseases. A key drug Ipsen will gain from the deal is Bylvay, a drug used to treat rare pediatric liver diseases, including children with pruritus in progressive familiar intrahepatic cholestasis (PFIC).

Insulin Manufacturers and PBMs Sued by State of California in Pricing Practices Dispute

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

The US state of California has filed suit against three major pharmacy benefit managers (PBMs) and the three largest insulin manufacturers over practices meant to spike the price of insulin. The pharma companies, including Novo Nordisk, Eli Lilly, and Sanofi, are accused of colluding, while the PBMs are accused of designing rebates to encourage manufacturers to raise list prices.

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